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 (SENOFILCON A) CONTACT LENSES |
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 | S010 |
Date Received | 01/25/2010 |
Decision Date | 02/23/2010 |
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 | Yes |
Approval Order Statement ADDITION OF AN ALTERNATE QUALIFIED SUPPLIER FOR AN INERT DILUENT USED IN THE PRODUCTION OF THE DEVICE. |
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