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 | VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES/CLEAR & TINTED (VISIBILITY AND COSMETICALLY) WITH UV BLOCKER |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. 7500 CENTURION PKWY. JACKSONVILLE, FL 32256 |
PMA Number | N18033 |
Supplement Number | S042 |
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 |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE STABILITY PROTOCOL UTILIZED TO ESTABLISH SHELF-LIFE. |
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