FDA PMA
FDA Class 2
Approved
🇺🇸 United States
Suture, Nonabsorbable, Synthetic, Polyester
PMA: N83509
·
Supplement: S005
·
Decision Jul 16, 1982
Classifications
1
FEI Numbers
44
Registration Numbers
44
Basic Information
- Device Name
- Suture, Nonabsorbable, Synthetic, Polyester
- Trade Name
- NON-ABSORBABLE (POLYESTER FIBER) SUTURES
- PMA Number
- N83509
- Supplement Number
- S005
- Device Class
- FDA Class 2
- Product Code
- GAS
- Generic Name
- Suture, nonabsorbable, synthetic, polyester
- Regulation Number
- 878.5000
- Medical Specialty
- General, Plastic Surgery
- Advisory Committee
- General, Plastic Surgery
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- July 16, 1982
- Date Received
- June 17, 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 |
|---|---|---|---|
| GAS | Suture, Nonabsorbable, Synthetic, Polyester | FDA class 2 | General, Plastic Surgery |