SOFLEX & SOFPORT POSTERIOR CHAMBER INTRAOCULAR LENSES
FDA premarket approval P910061/S019 · decided 2009-12-02
Approval details
- PMA number
- P910061
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SOFLEX & SOFPORT POSTERIOR CHAMBER INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb
- Date received
- 2009-11-02
- Decision date
- 2009-12-02
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- CHANGE IN THE BIOLOGICAL INDICATOR TESTING SITE FROM ALLIANCE MEDICAL PRODUCTS IN IRVINE, CALIFORNIA TO THE BAUSCH & LOMB FACILITY IN TAMPA, FLORIDA.
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