FDA PMA
FDA Class 2
Approved
🇺🇸 United States
Suture, Absorbable, Synthetic
PMA: N17482
·
Supplement: S034
·
Decision Dec 3, 1986
Classifications
1
FEI Numbers
31
Registration Numbers
31
Basic Information
- Device Name
- Suture, Absorbable, Synthetic
- Trade Name
- VICRYL MESH
- PMA Number
- N17482
- Supplement Number
- S034
- Device Class
- FDA Class 2
- Product Code
- GAN
- Generic Name
- Suture, absorbable, synthetic
- Regulation Number
- 878.4830
- Medical Specialty
- General, Plastic Surgery
- Advisory Committee
- General, Plastic Surgery
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 3, 1986
- Date Received
- October 28, 1986
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
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 |
|---|---|---|---|
| GAN | Suture, Absorbable, Synthetic | FDA class 2 | General, Plastic Surgery |