|
Device | 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 | S011 |
Date Received | 10/19/2004 |
Decision Date | 03/08/2005 |
Product Code |
LIT |
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 AN ALTERNATE IN-HOUSE STERILIZATION SITE LOCATED IN QUINCY, MASSACHUSETTS. |