COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES
FDA premarket approval P990013/S014 · decided 2008-01-25
Approval details
- PMA number
- P990013
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Starr Surgical Co.
- Date received
- 2007-11-29
- Decision date
- 2008-01-25
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- Statement
- APPROVAL FOR PARAMETRIC LOT RELEASE USING EXISTING VALIDATED STEAM STERILIZATION CYCLES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS AND IS INDICATED FOR THE VISUAL CORRECTION OF APHAKIA IN PERSONS 60 YEARS OF AGE OR OLDER IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATION CATARACT EXTRACTION. THE LENS IS TO BE IMPLANTED IN THE POSTERIOR CHAMBER AND IN THE CAPSULAR BAG THROUGH A TEAR-FREE CAPSULO
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