|
Device | PURE VISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS |
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 | S002 |
Date Received | 09/01/1999 |
Decision Date | 11/23/1999 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for: 1) adding a contraindication for the use of Allergan Ultracare disinfecting System to the product labeling (package insert/fitting guide and patient information booklet for frequent replacement wear); 2) removing references to thermal disinfection in the product labeling (package insert and patient information booklets); and 3) adding "The BAUSCH & LOMB(R) PureVision(TM) (balafilcon A) Visibility Tinted Contact Lenses are manufactured by a cast-molding process and are surface treated by the Performa(TM) surface treatment process which transforms hydrophobic silicone to hydrophilic silicate" to the Description section of the package insert/fitting guide. |