3M VISION CARE POSTERIOR CHAMBER IOL,PERSPEX CQ-UV
FDA premarket approval P830040/S025 · decided 1995-12-13
Approval details
- PMA number
- P830040
- Supplement
- S025
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- 3M VISION CARE POSTERIOR CHAMBER IOL,PERSPEX CQ-UV
- Generic name
- intraocular lens
- Applicant
- Alcon Research, Ltd.
- Date received
- 1995-08-09
- Decision date
- 1995-12-13
- Days to decision
- 126 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR AN ALTERNATE STERILIZATION PROCESS INCLUDING AERATION TIME AND THE ESTABLISHMENT OF THE BIOLOGICAL INDICATOR INCUBATION TIME
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