PMA P950032S045
- Device
- APLIGRAF
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S045
- Product code
- MGR
- Decision date
- 2010-08-17
- Classification
- Dressing, Wound And Burn, Interactive
- Generic name
- Dressing, wound and burn, interactive
- Approval order statement
- APPROVAL FOR REVISIONS TO THE DIABETIC FOOT ULCER AND VENOUS LEG ULCER PATIENT BROCHURES.
Current openFDA PMA Record#
- Device
- APLIGRAF
- Applicant
- Organogenesis, Inc.
- PMA number
- P950032
- Supplement
- S045
- Product code
- MGR
- Generic name
- Dressing, wound and burn, interactive
- Decision date
- 2010-08-17
- Decision code
- APPR
- Date received
- 2007-10-29
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISIONS TO THE DIABETIC FOOT ULCER AND VENOUS LEG ULCER PATIENT BROCHURES.