Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | VANTAGE (TETRAFILCON A ) CONTACT LENS |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | COOPERVISION, INC. 6150 Stoneridge Mall Road Suite 370 Pleasanton, CA 94588 |
PMA Number | N17679 |
Supplement Number | S029 |
Date Received | 03/01/1995 |
Decision Date | 07/28/1995 |
Product Code |
LPM |
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 REDUCTION OF THE INCUBATION TIEM OF THE BIOLOGICAL INDICATOR USED IN THE LENS STERILIZATION PROCESS TO FORTY-EIGHT HOURS. |
|
|