CHIROFLEX(TM) MODEL 32-C10XX SILICONE POS.CHA.IOL
FDA premarket approval P910058/S005 · decided 1994-08-11
Approval details
- PMA number
- P910058
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CHIROFLEX(TM) MODEL 32-C10XX SILICONE POS.CHA.IOL
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 1993-01-27
- Decision date
- 1994-08-11
- Days to decision
- 561 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
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