PMA P950032S035

Device: APLIGRAF
Applicant: Organogenesis, Inc.
PMA number: P950032
Supplement: S035
Product code: MGR
Decision date: 2003-09-15
Generic name: Dressing, wound and burn, interactive
Approval order statement: SUBSTITUTION OF THE CURRENT MANUFACTURER (ELI LILLY AND CO., DISTRIBUTED BY GIBCO) TO A DIFFERENT MANUFACTURER (NOVO NORDISK S/A, DISTRIBUTED BY GIBCO). ALSO, SUBSTITUTING NON-HUMAN COMPONENTS WITH HUMAN COMPONENTS.

Current openFDA PMA Record#

Device: APLIGRAF
Applicant: Organogenesis, Inc.
PMA number: P950032
Supplement: S035
Product code: MGR
Generic name: Dressing, wound and burn, interactive
Decision date: 2003-09-15
Decision code: OK30
Date received: 2003-08-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: SUBSTITUTION OF THE CURRENT MANUFACTURER (ELI LILLY AND CO., DISTRIBUTED BY GIBCO) TO A DIFFERENT MANUFACTURER (NOVO NORDISK S/A, DISTRIBUTED BY GIBCO). ALSO, SUBSTITUTING NON-HUMAN COMPONENTS WITH HUMAN COMPONENTS.