PMA P950032S014
- Device
- APLIGRAF(R) (GRAFTSKIN)
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S014
- Product code
- MGR
- Decision date
- 1999-10-14
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- Approval to introduce a new cell strain into the production of Apligraf (i.e., HEP 601).
Current openFDA PMA Record#
- Device
- APLIGRAF(R) (GRAFTSKIN)
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S014
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 1999-10-14
- Decision code
- APPR
- Date received
- 1999-09-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to introduce a new cell strain into the production of Apligraf (i.e., HEP 601).