|
Device | SILICON UV-ABSORBING POSTERIOR CHAMBER IOL |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | STAAR SURGICAL CO. 1911 WALKER AVE. MONROVIA, CA 91016 |
PMA Number | P880091 |
Supplement Number | S032 |
Date Received | 08/17/2010 |
Decision Date | 09/16/2010 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MODIFICATION TO THE DIRECTIONS FOR USE TO COMPLY WITH THE LATEST MEDICAL DEVICE DIRECTIVE (MDD) 93/42/EEC. |