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 | Biofinity XR Toric |
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 | S057 |
Date Received | 03/24/2017 |
Decision Date | 04/10/2017 |
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 Use of Biofinity Line 3 for the production of Biofinity XR Toric lenses with a sphere power range of 0.00D to +10.00D and cylinder powers of -2.75D to -4.25D. |
|
|