|
Device | SURGICAL COLLAMER UV-ABSORBING POSTERIOR IOL |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | STARR SURGICAL CO. 1911 WALKER AVE. MONROVIA, CA 91016 |
PMA Number | P990013 |
Supplement Number | S009 |
Date Received | 02/23/2007 |
Decision Date | 05/01/2007 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR IMPLEMENTATION OF THE IN-PROCESS BURST TESTING OF POUCHES USED ON THE COLLAMER IOLS. |