STAAR SURGICAL COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES
FDA premarket approval P990013/S023 · decided 2008-09-04
Approval details
- PMA number
- P990013
- Supplement
- S023
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- STAAR SURGICAL COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Starr Surgical Co.
- Date received
- 2008-08-04
- Decision date
- 2008-09-04
- Days to decision
- 31 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- CHANGE TO THE MODEL OF SILICONE/TEFLON SEPTA CURRENTLY USED TO MANUFACTURE COLLAMER¿ LENSES AT THE NIDAU, SWITZERLAND FACILITY.
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