PMA P010059S004

Device: EYEJET INJECTOR
Applicant: Morcher GmbH
PMA number: P010059
Supplement: S004
Product code: MRJ
Decision date: 2013-05-23
Generic name: Ring, endocapsular
Approval order statement: 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.

Current openFDA PMA Record#

Device: EYEJET INJECTOR
Applicant: Morcher GmbH
PMA number: P010059
Supplement: S004
Product code: MRJ
Generic name: Ring, endocapsular
Decision date: 2013-05-23
Decision code: APPR
Date received: 2011-11-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: 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.