FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Dressing, Wound And Burn, Interactive
PMA: P950032
·
Supplement: S059
·
Decision Feb 14, 2011
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
- S059
- 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
- February 14, 2011
- Date Received
- July 1, 2010
- Supplement Type
- 135 Review Track For 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
APPROVAL TO USE A RAPID MICROBIAL METHOD, AS AN ALTERNATE STERILITY TESTING METHOD FOR ALL IN-PROCESS LIQUID SAMPLES CURRENTLY TESTED PER UNITED STATES PHARMACOPEIA <71>, STERILITY TESTS.
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 |