|
Device | COOPERVISION COMFILCON A SOFT EXTENDED-WEAR CONTACT LENSES |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | CooperVision, Inc. 6101 Bollinger Canyon Road, Suite 500 San Ramon, CA 94583 |
PMA Number | P080011 |
Supplement Number | S030 |
Date Received | 02/27/2014 |
Decision Date | 07/08/2014 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Clinical Trials | NCT00597467
|
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A NEW MANUFACTURING LINE AT THE PUERTO RICO FACILITY. |