|
Device | BAUSCH & LOMB PUREVISION (BALAFILCON A) SOFT 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 | S016 |
Date Received | 12/01/2010 |
Decision Date | 12/27/2010 |
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 UPGRADE TO A PORTION OF THE MANUFACTURING PROCESS OF THE AUTOMATED AUTONOMOUS EXTENSIBLE GLOBAL INSPECTION SYSTEM (AEGIS) AND FREEDIAL WET VISION AUTOMATED INSPECTION SYSTEM (AIS). |