|
Device | ANGIOSCULPT(R) 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 | S022 |
Date Received | 06/08/2016 |
Decision Date | 09/06/2016 |
Product Code |
NWX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a non-patient contacting material change for a component of the AngioSculpt PTCA Scoring Balloon Catheter. |