FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Device, Dermal Replacement
PMA: P900033
·
Supplement: S031
·
Decision Aug 29, 2013
Classifications
1
FEI Numbers
5
Registration Numbers
5
Basic Information
- Device Name
- Device, Dermal Replacement
- Trade Name
- INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE
- PMA Number
- P900033
- Supplement Number
- S031
- 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
- August 29, 2013
- Date Received
- July 31, 2013
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
INCREASE IN THE SAMPLE SIZE FOR BACTERIAL ENDOTOXIN TESTING (BET) FOR ALL COLLAGEN PRODUCTS MANUFACTURED AT THE PLAINSBORO NEW JERSEY FACILITY AND AT THE ANASCO, PUERTO RICO LOCATION.
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 |