FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Dressing, Wound And Burn, Interactive
PMA: P900033
·
Supplement: S097
·
Decision Aug 12, 2021
Classifications
1
FEI Numbers
6
Registration Numbers
6
Basic Information
- Device Name
- Dressing, Wound And Burn, Interactive
- Trade Name
- Integra Dermal Regeneration Template and Integra Meshed Dermal Regeneration Template
- PMA Number
- P900033
- Supplement Number
- S097
- 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
- August 12, 2021
- Date Received
- July 16, 2021
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Qualification of upgrades to the lyophilizer system software and hardware.
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 |