|
Device | ANTERIOR CHAMBER INTRAOCULAR LENS |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | ALCON 6201 South Freeway Fort Worth, TX 76134-2099 |
PMA Number | P820035 |
Supplement Number | S014 |
Date Received | 08/09/1995 |
Decision Date | 12/13/1995 |
Withdrawal Date
|
12/30/1999 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE STERILIZATION PROCESS INCLUDING AERATION TIME AND THE ESTABLISHMENT OF THE BIOLOGICAL INDICATOR INCUBATION TIME |