PMA P950032S011
- Device
- APLIGRAF (GRAFTSKIN)
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S011
- Product code
- MGR
- Decision date
- 1999-06-24
- Classification
- Dressing, Wound And Burn, Interactive
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- Approval to use a new keratinocyte cell strain (i.e., HEP 608) in the manufacture of Apligraf.
Current openFDA PMA Record#
- Device
- APLIGRAF (GRAFTSKIN)
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S011
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 1999-06-24
- Decision code
- APPR
- Date received
- 1999-04-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to use a new keratinocyte cell strain (i.e., HEP 608) in the manufacture of Apligraf.