FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Intraocular Lens
PMA: P800016
·
Decision Mar 26, 1982
Classifications
1
FEI Numbers
59
Registration Numbers
59
Basic Information
- Device Name
- Intraocular Lens
- Trade Name
- TENNANT(TM) & KELMAN(TM) TYPE II
- PMA Number
- P800016
- Device Class
- FDA Class 3
- Product Code
- HQL
- Generic Name
- intraocular lens
- Regulation Number
- 886.3600
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- March 26, 1982
- Date Received
- April 15, 1980
- 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 |
|---|---|---|---|
| HQL | Intraocular Lens | FDA class 3 | Ophthalmic |