PMA P950032S034

Device: APLIGRAF
Applicant: Organogenesis, Inc.
PMA number: P950032
Supplement: S034
Product code: MGR
Decision date: 2002-10-15
Generic name: Dressing, wound and burn, interactive
Approval order statement: APPROVAL FOR THE INTRODUCTION OF A SODIUM HYDROXIDE STEP INTO THE BOVINE COLLAGEN PRODUCTION METHOD AND THE DISCONTINUATION OF VIRAL TESTING ON INDIVIDUAL LOTS OF COLLAGEN.

Current openFDA PMA Record#

Device: APLIGRAF
Applicant: Organogenesis, Inc.
PMA number: P950032
Supplement: S034
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2002-10-15
Decision code: APPR
Date received: 2002-08-05
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE INTRODUCTION OF A SODIUM HYDROXIDE STEP INTO THE BOVINE COLLAGEN PRODUCTION METHOD AND THE DISCONTINUATION OF VIRAL TESTING ON INDIVIDUAL LOTS OF COLLAGEN.