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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceBAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES-THERAPEUTIC USE
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantBausch & Lomb, Inc.
1400 NORTH GOODMAN ST.
ROCHESTER, NY 14609-3547
PMA NumberP980006
Supplement NumberS007
Date Received03/03/2005
Decision Date05/27/2005
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR ADDING A THERAPEUTIC INDICATION FOR THE PUREVISION CONTACT LENS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS FOR THERAPEUTIC USE AND IS INDICATED FOR THERAPEUTIC USE AS A BANDAGE CONTACT LENS FOR CORNEAL PROTECTION AND CORNEAL PAIN RELIEF DURING TREATMENT OF OCULAR PATHOLOGIES AS WELL AS POST-SURGICAL CONDITIONS. APPLICATIONS OF THE PUREVISION CONTACT LENS INCLUDE BUT ARE NOT LIMITED TO CONDITIONS SUCH AS THE FOLLOWING: 1) FOR CORNEAL PROTECTION IN CONDITIONS SUCH AS ENTROPION, TRICHIASIS, TARSAL SCARS, RECURRENT CORNEAL EROSION AND POST SURGICAL PTOSIS FOR CORNEAL PROTECTION; 2) FOR CORNEAL PAIN RELIEF IN CONDITIONS SUCH AS BULLOUS KERATOPATHY, EPITHELIAL EROSION AND ABRASION, FILAMENTARY KERATITIS, POST-KERATOPLASTY; 3) FOR USE AS A BANDAGE DURING THE HEALING PROCESS OF CONDITIONS SUCH AS CHRONIC EPITHELIAL DEFECTS, CORNEAL ULCER, NEUROTROPHIC KERATITIS, NEUROPARALYTIC KERATITIS, CHEMICAL BURNS, AND POST SURGICAL EPITHELIAL DEFECTS; AND 4) FOR POST SURGICAL CONDITIONS THAT INCLUDE BANDAGE USE SUCH AS LASIK, PRK, PK, PTK, LAMELLAR GRAFTS, CORNEAL FLAPS, AND ADDITIONAL CORNEAL SURGICAL CONDITIONS. PURE VISION CONTACT LENSES FOR THERAPEUTIC USE CAN ALSO PROVIDE CORRECTION DURING HEALING IF REQUIRED.
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