Documents > premarket approval application

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Premarket Submission Cover Sheet
Premarket Submission Cover Sheet
From: coryelJudie | Date: 8/18/2009 | Rated: 0 (0) | Views: 0
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Summary of Data & Information Contained in the PMA Summary Information This summary contains the following information: 1. General Information ...  more>>

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Premarket Approval Application Filing Review Guidance for Industry and FDA Staff
Premarket Approval Application Filing Review Guidance for Industry and FDA Staff
From: GovernmentDocs | Date: 5/4/2008 | Rated: 0 (0) | Views: 90
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Guidance for Industry and FDA Staff Premarket Approval Application Filing Review Document issued on: May 1, 2003 This document supersedes PMA Filing D ...  more>>

Tags: food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety
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Guidance for Industry and FDA Staff Premarket Approval Application Modular Review
Guidance for Industry and FDA Staff Premarket Approval Application Modular Review
From: GovernmentDocs | Date: 5/4/2008 | Rated: 0 (0) | Views: 224
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Guidance for Industry and FDA Staff Premarket Approval Application Modular Review Document issued on: November 3, 2003 This document supersedes and re ...  more>>

Tags: food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety
Categories: Legal > Government >
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Last Modified l l CONDITIONS OF APPROVAL PREMARKET
Last Modified l l CONDITIONS OF APPROVAL PREMARKET
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 12
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. . Last Modified: l-3 l-02 CONDITIONS OF APPROVAL PREMARKET APPROVAL APPLICATION (PMA) SUPPLEMENT. Before making any change affecting the ...  more>>

Tags: food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety
Categories: Legal > Government >
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To deny approval of Smith Nephew premarket approval application for the Birmingham Hip Resurfacing System
To deny approval of Smith Nephew premarket approval application for the Birmingham Hip Resurfacing System
From: FDADocs | Date: 5/8/2008 | Rated: 0 (0) | Views: 71
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Jefky G. Roberts Sr. Vice President & Chief Technical Officer Dmct Dial - 901-8674645 Facsimile - 901-867-8249 Email - Jrohertsic~;~mt~r 1056 5 ...  more>>

Tags: food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety
Categories: Legal > Government >
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Exhibit Summary PREMARKET NOTIFICATION
Exhibit Summary PREMARKET NOTIFICATION
From: FDADocs | Date: 5/5/2008 | Rated: 0 (0) | Views: 13
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1 Exhibit 1, Summary PREMARKET NOTIFICATION 510(k) SUMMARY As required by 5807.92 I i 1 Device Name - as required by 807.92(a)(2): Trade Name: ...  more>>

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PiccoloQPhosphorus Test System k Premarket Notification Whipple Road Union
PiccoloQPhosphorus Test System k Premarket Notification Whipple Road Union
From: Piecebypiece | Date: 2/26/2009 | Rated: 0 (0) | Views: 1
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PiccoloQPhosphorus Test System 510(k) Premarket Notification 3240 Whipple Road, Union City CA 94587 Phone 510 06756500 Fax 510 441-6150 This  ...  more>>

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New Dietary Ingredient Premarket Notification
New Dietary Ingredient Premarket Notification
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 40
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MTC Industries, Inc. Pharmaceuticals, Nutraceuticals and Biochemicals From, MTC Industries Inc. 299 East shore road, suite 207 Great Neck, NY 11023. ...  more>>

Tags: food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety
Categories: Legal > Government >
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Tympanostomy Tubes Submission Guidance for Premarket Notification Final
Tympanostomy Tubes Submission Guidance for Premarket Notification Final
From: GovernmentDocs | Date: 5/4/2008 | Rated: 0 (0) | Views: 55
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TYMPANOSTOMY TUBES Submission Guidance for a 510(k) Premarket Notification This document is intended to provide guidance in the preparation of a regu ...  more>>

Tags: food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety
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Letter from Technology Commercialization Corp to CFSAN Premarket Notification
Letter from Technology Commercialization Corp to CFSAN Premarket Notification
From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 22
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Technology Commercialization Michael W. Kenworthy 45 Tudcr CITY Place Suite 1619 New York, NY 10017-761 1 Carp, Telephone (212) 972-0233 Fax (212) ...  more>>

Tags: food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety
Categories: Legal > Government >
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Quality System Information for Certain Premarket Application Reviews Guidance for Industry and FDA Staff
Quality System Information for Certain Premarket Application Reviews Guidance for Industry and FDA Staff
From: GovernmentDocs | Date: 5/4/2008 | Rated: 0 (0) | Views: 56
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Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff Document issued on: February 3, 2003 This d ...  more>>

Tags: food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety
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Guidance for the Submission of PreMarket Notifications for Magnetic Resonance Diagnostic Devices FINAL
Guidance for the Submission of PreMarket Notifications for Magnetic Resonance Diagnostic Devices FINAL
From: GovernmentDocs | Date: 5/4/2008 | Rated: 0 (0) | Views: 44
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Guidance for Industry Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices Document issued on: November 1 ...  more>>

Tags: food and drug administration, FDA, FDA documents, FDA reports, FDA approval, FDA regulations, FDA recall, food safety, FDA news, department of public safety
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