FDA PMA
FDA Class 2
Approved
🇺🇸 United States
Suture, Nonabsorbable, Synthetic, Polyamide
PMA: N83511
·
Supplement: S005
·
Decision Mar 2, 1983
Classifications
1
FEI Numbers
120
Registration Numbers
120
Basic Information
- Device Name
- Suture, Nonabsorbable, Synthetic, Polyamide
- Trade Name
- NON-ABSORBABLE SUTURES NYLON
- PMA Number
- N83511
- Supplement Number
- S005
- Device Class
- FDA Class 2
- Product Code
- GAR
- Generic Name
- Suture, nonabsorbable, synthetic, polyamide
- Regulation Number
- 878.5020
- Medical Specialty
- General, Plastic Surgery
- Advisory Committee
- General, Plastic Surgery
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 2, 1983
- Date Received
- December 29, 1982
- 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 |
|---|---|---|---|
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | FDA class 2 | General, Plastic Surgery |