SOFLEX UV ABSORBING SILICONE POSTERIOR CHAMBER IOLS
FDA premarket approval P910061/S008 · decided 1999-03-15
Approval details
- PMA number
- P910061
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SOFLEX UV ABSORBING SILICONE POSTERIOR CHAMBER IOLS
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb
- Date received
- 1999-02-10
- Decision date
- 1999-03-15
- Days to decision
- 33 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for minor revision to the labeling and an alternate sterilization method.
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