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 | DRIVER OVER THE WIRE (OTW) & DRIVER MULTI-EXCHANGE (MX) CORONARY STENT SYSTEMS |
Generic Name | STENT, CORONARY |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P030009 |
Supplement Number | S018 |
Date Received | 01/14/2008 |
Decision Date | 02/13/2008 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement INCREASING THE MARKER BAND SPACING OF THE STENT INNER SUB-ASSEMBLY BY 0.5 MM FOR THE 24 MM AND 3 MM STENT LENGTHS OF THE DEVICES. |
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