PMA P950032S018
- Device
- APLIGRAF(R)
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S018
- Product code
- MGR
- Decision date
- 2000-08-31
- Classification
- Dressing, Wound And Burn, Interactive
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- APPROVAL TO INTRODUCE NEW CELL STRAINS INTO THE PRODUCTION OF APLIGRAF (I.E., HDF B677 AND HEP B677).
Current openFDA PMA Record#
- Device
- APLIGRAF(R)
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S018
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2000-08-31
- Decision code
- APPR
- Date received
- 2000-08-08
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO INTRODUCE NEW CELL STRAINS INTO THE PRODUCTION OF APLIGRAF (I.E., HDF B677 AND HEP B677).