KELMAN(TM) OMNIFIT II MODEL 2100
FDA premarket approval P850059/S009 · decided 1990-04-11
Approval details
- PMA number
- P850059
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- KELMAN(TM) OMNIFIT II MODEL 2100
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb Surgical, Inc.
- Date received
- 1988-12-19
- Decision date
- 1990-04-11
- Days to decision
- 478 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.