PMA P950032S055

Device: APLIGRAF
Applicant: Organogenesis, Inc.
PMA number: P950032
Supplement: S055
Product code: MGR
Decision date: 2009-12-23
Generic name: Dressing, wound and burn, interactive
Approval order statement: ADDITION OF AN ALTERNATE MATERIAL SUPPLIER, HYCLONE (LOGAN, UTAH), FOR BULK MEDIA CONTAINING HUMAN (APO) TRANSFERRIN WHICH IS USED IN THE PRODUCTION BULK MEDIA FOR THE PROCESSING OF APLIGRAF.

Current openFDA PMA Record#

Device: APLIGRAF
Applicant: Organogenesis, Inc.
PMA number: P950032
Supplement: S055
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2009-12-23
Decision code: OK30
Date received: 2009-11-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF AN ALTERNATE MATERIAL SUPPLIER, HYCLONE (LOGAN, UTAH), FOR BULK MEDIA CONTAINING HUMAN (APO) TRANSFERRIN WHICH IS USED IN THE PRODUCTION BULK MEDIA FOR THE PROCESSING OF APLIGRAF.