SOFLEX UV ABSORBING SILICONE POSTERIOR INTRAOCULAR LENSES
FDA premarket approval P910061/S007 · decided 1999-03-08
Approval details
- PMA number
- P910061
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SOFLEX UV ABSORBING SILICONE POSTERIOR INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb
- Date received
- 1998-12-18
- Decision date
- 1999-03-08
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for a manufacturing qualification protocol and a manufacturing site located at 21 Park Place Blvd., N., Clearwater, FL 33759.
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| STELLARIS VISION ENHANCEMENT SYSTEM (K133242) | Bausch & Lomb | 2014-02-14 |
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| EASY-LOAD LENS DELIVERY SYSTEM (K132481) | Bausch & Lomb | 2013-12-27 |
| CRYSTALSERT DELIVERY SYSTEM (K132593) | Bausch & Lomb | 2013-09-17 |