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 | VERIFLEX MR CORONARY STENT SYSTEM & VERIFLEX OTW CORONARY STENT SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | BOSTON SCIENTIFIC SCIMED, INC. One Scimed Place Maple Grove, MN 55311 |
PMA Number | P040016 |
Supplement Number | S073 |
Date Received | 06/21/2011 |
Decision Date | 03/23/2012 |
Withdrawal Date
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12/06/2018 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT ISOTRON NETHERLAND BV, VENLO, THE NETHERLANDS. |
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