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 PMS US STUDY NIRTRAKS |
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 | S021 |
Date Received | 12/05/2016 |
Decision Date | 02/10/2017 |
Withdrawal Date
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11/02/2020 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for cessation of patient enrollment in this PAS for the post-approval study (PAS). |
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