PMA P950032S059

Device: APLIGRAF
Applicant: Organogenesis, Inc.
PMA number: P950032
Supplement: S059
Product code: MGR
Decision date: 2011-02-14
Classification: Dressing, Wound And Burn, Interactive
Generic name: Dressing, wound and burn, interactive
Approval order statement: APPROVAL TO USE A RAPID MICROBIAL METHOD, AS AN ALTERNATE STERILITY TESTING METHOD FOR ALL IN-PROCESS LIQUID SAMPLES CURRENTLY TESTED PER UNITED STATES PHARMACOPEIA <71>, STERILITY TESTS.

Current openFDA PMA Record#

Device: APLIGRAF
Applicant: Organogenesis, Inc.
PMA number: P950032
Supplement: S059
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2011-02-14
Decision code: APPR
Date received: 2010-07-01
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL TO USE A RAPID MICROBIAL METHOD, AS AN ALTERNATE STERILITY TESTING METHOD FOR ALL IN-PROCESS LIQUID SAMPLES CURRENTLY TESTED PER UNITED STATES PHARMACOPEIA , STERILITY TESTS.