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 | ALCON REFORM CAPSULAR TENSION RING |
Generic Name | Ring, endocapsular |
Applicant | MORCHER GMBH KAPUZINERWEG 12 STUTTGART, WURTTEMBERG-BADEN D-703-7037 |
PMA Number | P010059 |
Supplement Number | S001 |
Date Received | 01/20/2004 |
Decision Date | 03/15/2004 |
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 Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A PRIVATE LABEL DISTRIBUTOR AGREEMENT WITH ALCON LABORATORIES, INC., FORT WORTH, TEXAS. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME ALCON REFORM CAPSULAR TENSION RINGS (MODELS ACTR10, ACTR11, AND ACTR12). |
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