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 | ANGIOSCULPT 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 | S003 |
Date Received | 05/30/2007 |
Decision Date | 10/18/2007 |
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 A MANUFACTURING SITE LOCATED AT ANGIOSCORE, INC., FREMONT, CALIFORNIA. |
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