Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• 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: S014
• Date Received: 06/11/2014
• Decision Date: 09/12/2014
• Product Code: NCJ
• Advisory Committee: Ophthalmic
• Supplement Type: Real-Time Process
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
MODIFICATION OF A PROCESS USED TO MANUFACTURE THE CATHETERS¿ QUAD LUMEN SOFT TIP.