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 (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 | S017 |
Date Received | 12/01/2010 |
Decision Date | 12/27/2010 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement REDUCTION OF THE SAMPLE SIZE TESTING PHYSICAL PROPERTIES ACCEPTANCE CRITERIA DURING THE USE OF THE AUTOMATED INSPECTION SYSTEM FOR THE PUREVISION (BALAFILCON A) CONTACT LENSES. THIS CHANGE OF THE SAMPLING PLAN APPLIES ONLY TO BAUSCH & LOMB¿S WATERFORD, IRELAND FACILITY. |
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