|
Device | FLEXTOME CUTTING BALLOON MONORAIL(MR) AND OVER THE WIRE (OTW) |
Generic Name | Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P950020 |
Supplement Number | S013 |
Date Received | 09/12/2005 |
Decision Date | 09/29/2008 |
Product Code |
NWX |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MANUFACTURING SITES LOCATED AT BOSTON SCIENTIFIC CORPORATION, IN MAPLE GROVE, MINNESOTA AND PLYMOUTH, MINNESOTA FOR THE MANUFACTURE OF THE BALLOON COMPONENT OF THE DEVICE. |