PMA P950032S008
- Device
- APLIGRAF (GRAFTSKIN)
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S008
- Product code
- MGR
- Decision date
- 1999-02-23
- Classification
- Dressing, Wound And Burn, Interactive
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- Approval for a protocol for evaluating the karyology of keratinocyte and fibroblast cell strains used in Apligraf manufacture.
Current openFDA PMA Record#
- Device
- APLIGRAF (GRAFTSKIN)
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S008
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 1999-02-23
- Decision code
- APPR
- Date received
- 1998-12-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for a protocol for evaluating the karyology of keratinocyte and fibroblast cell strains used in Apligraf manufacture.