Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: IMPLANTABLE MINIATURE TELESCOPE
• Classification Name: telescope, implantable, miniature
• Applicant: VISION CARE OPHTHALMIC TECHNOLOGIES, LTD.
• PMA Number: P050034
• Supplement Number: S003
• Date Received: 09/29/2010
• Decision Date: 10/29/2010
• Product Code: NCJ [ Registered Establishments with NCJ ]
• Advisory Committee: Ophthalmic
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Introduction of an additional laser welding system ii.