Note: 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. |
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Device | EYEJET INJECTOR |
Generic Name | Ring, endocapsular |
Applicant | MORCHER GMBH KAPUZINERWEG 12 STUTTGART, WURTTEMBERG-BADEN D-703-7037 |
PMA Number | P010059 |
Supplement Number | S004 |
Date Received | 11/08/2011 |
Decision Date | 05/23/2013 |
Product Code |
MRJ |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |
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