FDA PMA
FDA Class 2
Approved (Reclassification)
🇺🇸 United States
Suture, Nonabsorbable, Synthetic, Polypropylene
PMA: P890002
·
Decision May 31, 1989
Classifications
1
FEI Numbers
111
Registration Numbers
111
Basic Information
- Device Name
- Suture, Nonabsorbable, Synthetic, Polypropylene
- Trade Name
- POLYPROPYLENE SURGICAL SUTURE
- PMA Number
- P890002
- Device Class
- FDA Class 2
- Product Code
- GAW
- Generic Name
- Suture, nonabsorbable, synthetic, polypropylene
- Regulation Number
- 878.5010
- Medical Specialty
- General, Plastic Surgery
- Advisory Committee
- General, Plastic Surgery
- Decision
- Approved (Reclassification)
- Decision Code
- APRL
- Decision Date
- May 31, 1989
- Date Received
- January 6, 1989
- Expedited Review
- N
- Docket Number
- 89M-0197
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 |
|---|---|---|---|
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | FDA class 2 | General, Plastic Surgery |