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. |
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Device | BAUSCH & LOMB PUREVISION/PUREVISION 2 (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | Bausch & Lomb, Inc. 1400 NORTH GOODMAN ST. ROCHESTER, NY 14609-3547 |
PMA Number | P980006 |
Supplement Number | S014 |
Date Received | 11/12/2008 |
Decision Date | 05/05/2009 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE USE OF AN ALTERNATE RESIN SUNOCO D-115A TO FORM THE BLISTER PACKAGE CONTAINER FOR THE DEVICE. |
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