IMPLANTABLE MINIATURE TELESCOPE (IMT)

Telescope, Implantable, Miniature

FDA Premarket Approval P050034 S016

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.

Pre-market Approval Supplement Details

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.

• Device: IMPLANTABLE MINIATURE TELESCOPE (IMT)
• Classification Name: Telescope, Implantable, Miniature
• Generic Name: Telescope, Implantable, Miniature
• Applicant: VISIONCARE, INC.
• Date Received: 2016-09-23
• Decision Date: 2016-12-20
• PMA: P050034
• Supplement: S016
• Product Code: NCJ
• Advisory Committee: Ophthalmic
• Supplement Type: Real-time Process
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: VISIONCARE, INC. 14395 Saratoga Avenue #150 saratoga, CA 95070

Supplemental Filings

Supplement Number	Date	Supplement Type
P050034		Original Filing
S020	2018-09-11	Normal 180 Day Track No User Fee
S019	2017-09-21	30-day Notice
S018
S017	2016-09-26	30-day Notice
S016	2016-09-23	Real-time Process
S015	2014-11-28	Normal 180 Day Track No User Fee
S014	2014-06-11	Real-time Process
S013	2013-12-26	Normal 180 Day Track
S012	2013-12-12	30-day Notice
S011	2013-08-08	30-day Notice
S010	2013-07-16	30-day Notice
S009	2013-05-15	Normal 180 Day Track No User Fee
S008	2012-12-20	30-day Notice
S007	2012-12-04	30-day Notice
S006	2011-12-27	Real-time Process
S005	2011-03-02	30-day Notice
S004	2010-12-15	Real-time Process
S003	2010-09-29	30-day Notice
S002	2010-08-30	Normal 180 Day Track No User Fee
S001	2010-08-30	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
M687PR00020000	P050034	012
M687PR00018000	P050034	012