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Device | IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X |
Generic Name | Telescope, implantable, miniature |
Applicant | Samsara Vision Inc. 27 US Highway 202 Suite 8/9 Far Hills, NJ 07931 |
PMA Number | P050034 |
Supplement Number | S012 |
Date Received | 12/12/2013 |
Decision Date | 01/15/2014 |
Product Code |
NCJ |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement POSSIBILITY OF REWORK AND RETESTING ACTIVITIES. |