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Device | VISTAKON (SENOFILCON A) CONTACT LENSES CLEAR/VISIBILITY TINTED WITH UV BLOCKER |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | VISTAKON, DIVISION OF JOHNSON & JOHNSON VISION CAR 7500 CENTURION PARKWAY SUITE 100 - ERCA JACKSONVILLE, FL 32256 |
PMA Number | P040045 |
Supplement Number | S007 |
Date Received | 06/22/2009 |
Decision Date | 02/19/2010 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE STABILITY PROTOCOL UTILIZED TO ESTABLISH SHELF-LIFE. |