PMA P950032S040
- Device
- APLIGRAF
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S040
- Product code
- MGR
- Decision date
- 2005-04-25
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- CHANGES TO THE FORMULATION OF THE TRYPSIN QUENCHING SOLUTION USED IN THE APLIGRAF MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- APLIGRAF
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S040
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2005-04-25
- Decision code
- OK30
- Date received
- 2005-04-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE FORMULATION OF THE TRYPSIN QUENCHING SOLUTION USED IN THE APLIGRAF MANUFACTURING PROCESS.