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 | BAUSCH & LOMB SILSOFT (ELASTOFILCON A) CONTACT LENS |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | Bausch & Lomb, Inc. 14853 DEVEAU PLACE MINNETONKA, MN 55345 |
PMA Number | P850068 |
Supplement Number | S009 |
Date Received | 09/14/2011 |
Decision Date | 10/14/2011 |
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 CHANGE THE MANUFACTURING PROCESS OF THE OPTICAL TOOLS USED TO MANUFACTURE THE DEVICE. |
|
|