|
Device | ANGIOSCULPT PTCA SCORING BALLOON CATHETER,RAPID EXCHANGE (RX0 |
Generic Name | Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring |
Applicant | SPECTRANETICS CORP. 5055 BRANDIN COURT FREMONT, CA 94538 |
PMA Number | P050018 |
Supplement Number | S014 |
Date Received | 04/13/2011 |
Decision Date | 05/12/2011 |
Product Code |
NWX |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement MANUFACTURING CHANGE TO INCLUDE A NEW PART NUMBER FOR THE DEVICE AND THE PURCHASE OF THE OEM RAPID EXCHANGE BALLOON CATHETER MANUFACTURED BY A QUALIFIED SUPPLIER. |