FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Dressing, Wound And Burn, Interactive
PMA: P950032
·
Supplement: S055
·
Decision Dec 23, 2009
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
- S055
- Device Class
- FDA Class 3
- Product Code
- MGR
- Generic Name
- Dressing, wound and burn, interactive
- Medical Specialty
- Unknown
- Advisory Committee
- General, Plastic Surgery
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- December 23, 2009
- Date Received
- November 23, 2009
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
ADDITION OF AN ALTERNATE MATERIAL SUPPLIER, HYCLONE (LOGAN, UTAH), FOR BULK MEDIA CONTAINING HUMAN (APO) TRANSFERRIN WHICH IS USED IN THE PRODUCTION BULK MEDIA FOR THE PROCESSING 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 |