|
Device | IMPLANTABLE MINIATURE TELESCOPE (IMT) |
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 | S016 |
Date Received | 09/23/2016 |
Decision Date | 12/20/2016 |
Product Code |
NCJ |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a design change to reposition the eyelet on each haptic (loop) of the carrier of the IMT to the distal end of the haptic. |