|
Device | SOFTCON EW 2 & SOFT-55 EW APHAKIC SOFT CONTACT LENSES |
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 | S003 |
Date Received | 12/31/2007 |
Decision Date | 03/03/2008 |
Withdrawal Date
|
05/12/2014 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO BEGIN PARAMETRIC RELEASE FOR HYDROPHILIC LENSES PACKAGED IN VIALS. |