FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Dressing, Wound And Burn, Interactive
PMA: P950032
·
Supplement: S060
·
Decision Oct 26, 2010
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Dressing, Wound And Burn, Interactive
- Trade Name
- APLIGRAF
- PMA Number
- P950032
- Supplement Number
- S060
- Device Class
- FDA Class 3
- Product Code
- MGR
- Generic Name
- Dressing, wound and burn, interactive
- Medical Specialty
- Unknown
- Advisory Committee
- General, Plastic Surgery
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 26, 2010
- Date Received
- September 22, 2010
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE INTRODUCTION OF KERATINOCYTE CELL STRAIN (HEP074) INTO THE MANUFACTURE OF APLIGRAF.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MGR | Dressing, Wound And Burn, Interactive | FDA class 3 | Unknown |