FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Device, Dermal Replacement
PMA: P900033
·
Supplement: S012
·
Decision Sep 17, 2004
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Device, Dermal Replacement
- Trade Name
- INTEGRA DERMAL REGENERATION TEMPLATE
- PMA Number
- P900033
- Supplement Number
- S012
- Device Class
- FDA Class 3
- Product Code
- MDD
- Generic Name
- Device, dermal replacement
- Medical Specialty
- Unknown
- Advisory Committee
- General, Plastic Surgery
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- September 17, 2004
- Date Received
- August 23, 2004
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
EXTENSION OF THE ALLOWED HOLDING TIME FOR ONE OF THE MANUFACTURING PROCESSES.
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 |
|---|---|---|---|
| MDD | Device, Dermal Replacement | FDA class 3 | Unknown |