|
Device | Implantable Miniature Telescope |
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 | S019 |
Date Received | 09/21/2017 |
Decision Date | 10/20/2017 |
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 Alternate supplier for a component of the telescope sub-assembly for Models Wide Angle 2.2X and Wide Angle 2.7X. |