EYEJET INJECTOR

FDA Premarket Approval P010059 S004

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 the expansion of your family of capsular tension rings (ctrs) available pre-loaded on the eyejet injector to include new ctr models type 10g, 10l, 15, 15a, and 15b. In addition, you requested approval to supply currently approved ctr type 10c as pre-loaded on the eyejet injector.

• Device: EYEJET INJECTOR
• Generic Name: Ring, Endocapsular
• Applicant: MORCHER GMBH
• Date Received: 2011-11-08
• Decision Date: 2013-05-23
• PMA: P010059
• Supplement: S004
• Product Code: MRJ
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• 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