|
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 | S007 |
Date Received | 12/04/2012 |
Decision Date | 12/27/2012 |
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 IMPLEMENTATION OF A HOLDING SYSTEM USING NITROGEN GAS IN LASER WELDING SYSTEM I (LWSI). |