UV-ABSORBING PMMA ANTERIOR CHAMBER IOLS
FDA premarket approval P850059/S023 · decided 2001-05-08
Approval details
- PMA number
- P850059
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- UV-ABSORBING PMMA ANTERIOR CHAMBER IOLS
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb Surgical, Inc.
- Date received
- 1999-09-21
- Decision date
- 2001-05-08
- Days to decision
- 595 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR THE MANUFACTURE OF THE HMWX-PMMA AND CC MII BLANK MATERIALS IN THE PRODUCTION OF PMMA INTRAOCULAR LENSES AT THE BAUSCH & LOMB SURGICAL, CLEARWATER, FLORIDA FACILITY.
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