|
Device | CHIROFLEX(TM)MODEL C10UB ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Bausch & Lomb, Inc. 1400 NORTH GOODMAN ST. ROCHESTER, NY 14609-3547 |
PMA Number | P910058 |
Supplement Number | S008 |
Date Received | 12/01/1995 |
Decision Date | 01/02/1996 |
Withdrawal Date
|
09/17/2010 |
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 FOR ALLERGAN MEDICAL OPTICS TO DISTRIBUTE YOUR CHIROFLEX MODEL C1OUB ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS AS THE AMO SINGLFLEX MODEL SI-14PB ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER IOL |