|
Device | ANGIOSCULPT PTCA SCORING BALLOON CATHETER |
Generic Name | Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring |
Applicant | SPECTRANETICS CORP. 5055 BRANDIN COURT FREMONT, CA 94538 |
PMA Number | P050018 |
Supplement Number | S012 |
Date Received | 12/02/2010 |
Decision Date | 03/30/2011 |
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 |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED IN SALT LAKE CITY, UTAH. |