PMA P950032S037
- Device
- APILGRAF
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S037
- Product code
- MGR
- Decision date
- 2004-01-23
- Classification
- Dressing, Wound And Burn, Interactive
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- TWO MANUFACTURING CHANGES INVOLVING THE SEED POOL PRODUCTION PROCESS.
Current openFDA PMA Record#
- Device
- APILGRAF
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S037
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2004-01-23
- Decision code
- OK30
- Date received
- 2003-12-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- TWO MANUFACTURING CHANGES INVOLVING THE SEED POOL PRODUCTION PROCESS.