FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Barrier, Absorbable, Adhesion
PMA: P950034
·
Decision Aug 12, 1996
Classifications
1
FEI Numbers
17
Registration Numbers
17
Basic Information
- Device Name
- Barrier, Absorbable, Adhesion
- Trade Name
- SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE
- PMA Number
- P950034
- Device Class
- FDA Class 3
- Product Code
- MCN
- Generic Name
- Barrier, absorbable, adhesion
- Medical Specialty
- Unknown
- Advisory Committee
- General, Plastic Surgery
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 12, 1996
- Date Received
- October 27, 1995
- Expedited Review
- Y
- Docket Number
- 97M-0139
Advisory Committee Statement
APPROVAL FOR THE SEPRAFILM BIORESORBABLE MEMBRANE
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 |
|---|---|---|---|
| MCN | Barrier, Absorbable, Adhesion | FDA class 3 | Unknown |