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 | SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR) |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | UNILENS CORPORATION USA 10431 72nd Street North Largo, FL 33777 |
PMA Number | P960039 |
Supplement Number | S001 |
Date Received | 06/25/1998 |
Decision Date | 07/09/1998 |
Withdrawal Date
|
05/12/2014 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Requested that the device which is terminally sterilized by steam sterilization, be released into distribution using parametric criteria rather than the existing Biological Indicators. |
|
|