KELMAN(TM) OMNIFIT II MODEL 2100
FDA premarket approval P850059/S008 · decided 1988-10-03
Approval details
- PMA number
- P850059
- Supplement
- S008
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- KELMAN(TM) OMNIFIT II MODEL 2100
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb Surgical, Inc.
- Date received
- 1988-08-22
- Decision date
- 1988-10-03
- Days to decision
- 42 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.