|
Device | SINGLE-PIECE AND THREE PIECE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS) |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | ADVANCED VISION SCIENCE 5743 THORNWOOD DR. GOLETA, CA 93117 |
PMA Number | P830033 |
Supplement Number | S027 |
Date Received | 07/28/1994 |
Decision Date | 01/29/1996 |
Withdrawal Date
|
10/22/2008 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO CHANGE VENDORS OF THE POLYMETHYLMETHACRYLATE (PMMA) MATERIAL USED TO MANUFACTURE IOLS APROVED UNDER THIS PMA AND ITS SUPPLEMENTS |