PMA P950032S007
- Device
- APLIGRAF (GRAFTSKIN)
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S007
- Product code
- MGR
- Decision date
- 1999-02-01
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- Approval for responses to condition of approval cited in FDA's 5/22/98 Approval Order, i.e., concerning the purity of the transferrin used in device manufacture.
Current openFDA PMA Record#
- Device
- APLIGRAF (GRAFTSKIN)
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S007
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 1999-02-01
- Decision code
- APPR
- Date received
- 1998-11-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for responses to condition of approval cited in FDA's 5/22/98 Approval Order, i.e., concerning the purity of the transferrin used in device manufacture.