PMA P950032S061
- Device
- APLIGRAF
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S061
- Product code
- MGR
- Decision date
- 2011-01-07
- Classification
- Dressing, Wound And Burn, Interactive
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- APPROVAL FOR THE ADDITION OF FINISHED PRODUCT ENDOTOXIN RELEASE TESTING FOR APLIGRAF.
Current openFDA PMA Record#
- Device
- APLIGRAF
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S061
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2011-01-07
- Decision code
- APPR
- Date received
- 2010-12-08
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF FINISHED PRODUCT ENDOTOXIN RELEASE TESTING FOR APLIGRAF.