PMA P950032S066
- Device
- APLIGRAF
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S066
- Product code
- MGR
- Decision date
- 2011-12-28
- Classification
- Dressing, Wound And Burn, Interactive
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- APPROVAL FOR THE INTRODUCTION OF A NEW FIBROBLAST CELL STRAIN (HDF 167) IN THE COMMERCIAL PRODUCTION OF APLIGRAF.
Current openFDA PMA Record#
- Device
- APLIGRAF
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S066
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2011-12-28
- Decision code
- APPR
- Date received
- 2011-12-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE INTRODUCTION OF A NEW FIBROBLAST CELL STRAIN (HDF 167) IN THE COMMERCIAL PRODUCTION OF APLIGRAF.