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 | NIRXCELL COCR CORONARY STENT ON RX SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | MEDINOL LTD. KIRYAT ATIDIM, BLDG. 7 ENTRANCE A, P.O.B. 58165 TEL-AVIV 61581 |
PMA Number | P110004 |
Supplement Number | S001 |
Date Received | 02/22/2013 |
Decision Date | 12/19/2013 |
Withdrawal Date
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11/02/2020 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
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 MODIFICATIONS TO THE STENT DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NIRXCELL COCR CORONARY STENT ON RX SYSTEM AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE ASSOCIATED WITH STENOTIC LESIONS IN DE NOVO NATIVE CORONARY ARTERIES (LENGTH ¿30MM) WITH A REFERENCE VESSEL DIAMETER OF 2.50MM TO 4.00MM. |
Post-Approval Study | Show Report Schedule and Study Progress |
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