BAUSCH & LOMB SURGICAL SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER LENS
FDA premarket approval P910061/S006 · decided 1998-12-14
Approval details
- PMA number
- P910061
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BAUSCH & LOMB SURGICAL SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER LENS
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb
- Date received
- 1998-12-01
- Decision date
- 1998-12-14
- Days to decision
- 13 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for the addition of a tumbling and an alternative extraction process to the manufacture of silicone lenses.
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