Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | STARR SURGICAL CO. 1911 WALKER AVE. MONROVIA, CA 91016 |
PMA Number | P990013 |
Supplement Number | S014 |
Date Received | 11/29/2007 |
Decision Date | 01/25/2008 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order 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 CAPSULORHEXIS (CIRCULAR TEAR ANTERIOR CAPSULOTOMY). |
|
|