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 | FLEXTOME CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW) |
Generic Name | Catheter, angioplasty, peripheral, transluminal |
Regulation Number | 870.1250 |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P950020 |
Supplement Number | S010 |
Date Received | 09/13/2004 |
Decision Date | 07/18/2005 |
Product Code |
LIT |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR DESIGN, MANUFACTURING, AND LABELING CHANGES IN THE CUTTING BALLOON, BOTH OVER-THE-WIRE (OTW) AND MONORAIL (MR) CONFIGURATIONS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FLEXTOME CUTTING BALLOON AND IS INDICATED FOR DILATATION OF STENOSES IN CORONARY ARTERIES FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION IN THOSE CIRCUMSTANCES WHERE A HIGH PRESSURE BALLOON RESISTANT LESION IS ENCOUNTERED. |
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