FortiEYE CAPSULAR TENSION RINGS, TYPES 14, 14A AND 14C

FDA Premarket Approval P010059 S006

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 new private labeling for an alternative distributor.

• Device: FortiEYE CAPSULAR TENSION RINGS, TYPES 14, 14A AND 14C
• Generic Name: Ring, Endocapsular
• Applicant: MORCHER GMBH
• Date Received: 2016-08-02
• Decision Date: 2017-01-26
• PMA: P010059
• Supplement: S006
• Product Code: MRJ
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: MORCHER GMBH kapuzinerweg 12 stuttgart, Wurttemberg-baden D-703-7037

Supplemental Filings

Supplement Number	Date	Supplement Type
P010059		Original Filing
S006	2016-08-02	Normal 180 Day Track No User Fee
S005
S004	2011-11-08	Normal 180 Day Track
S003	2007-03-19	Real-time Process
S002	2004-08-03	Normal 180 Day Track
S001	2004-01-20	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
04048509620004	P010059	007