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 | POLYMACON CONTACT LENSES |
Generic Name | Lenses, soft contact, extended wear |
Applicant | COOPERVISION, INC. 370 WOODCLIFF DRIVE SUITE 200 FAIRPORT, NY 14450-0000 |
PMA Number | P780007 |
Supplement Number | S041 |
Date Received | 02/06/1996 |
Decision Date | 09/27/1996 |
Product Codes |
LPL 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 AN ALTERNATE MANUFACTURING FACILITY FOR THE REFERENCED DEVICE AT RELIANT CLOSE, CHANDLERS FORD INDUSTRIAL ESTATE, CHANDLERS FORD, EASTLEIGH, HAMPSHIRE, S053 4ND, ENGLAND |
|
|