FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Aid, Surgical, Viscoelastic
PMA: P820079
·
Decision Sep 30, 1986
Classifications
1
FEI Numbers
27
Registration Numbers
27
Basic Information
- Device Name
- Aid, Surgical, Viscoelastic
- Trade Name
- CDS II (SODIUM CHONDROITIN SULFATE)
- PMA Number
- P820079
- Device Class
- FDA Class 3
- Product Code
- LZP
- Generic Name
- AID, SURGICAL, VISCOELASTIC
- Regulation Number
- 886.4275
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- September 30, 1986
- Date Received
- October 25, 1982
- Expedited Review
- N
- Docket Number
- 86M-0408
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 |
|---|---|---|---|
| LZP | Aid, Surgical, Viscoelastic | FDA class 3 | Ophthalmic |