|
Device | VISTAKON (ETAFILCON A) CONTACT LENS |
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 | S045 |
Date Received | 03/10/2010 |
Decision Date | 08/26/2010 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW IN-PROCESS CONTROL POINT. |