FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Dressing, Wound And Burn, Interactive
PMA: P960007
·
Supplement: S015
·
Decision Aug 30, 2001
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Dressing, Wound And Burn, Interactive
- Trade Name
- TRANSCYTE/HUMAN FIBROBLAST DERIVED TEMPORARY SKIN SUBSTITUTE
- PMA Number
- P960007
- Supplement Number
- S015
- 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
- August 30, 2001
- Date Received
- June 26, 2001
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR AMENDED LABELING TO INCLUDE INFORMATION REGARDING THE RESULTS OF TESTING THE DONOR MOTHER'S SERA FOR VIRUSES AND OTHER INFECTIOUS AGENTS.
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 |