FDA PMA Number P050018, ANGIOSCULPT SCORING BALLOON CATHETER
FDA PMA Number P050018, ANGIOSCULPT SCORING BALLOON CATHETER
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Contents: PMA submission for Spectranetics Corp. Angiosculpt Balloon Catheter
PMA Number: P050018
Device: ANGIOSCULPT SCORING BALLOON CATHETER
Generic Name: Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Manufacturer: SPECTRANETICS CORP.
Product Code: NWX
Date Received: 05/11/2005
Decision Date: 01/08/2007
Notice Date: 01/23/2007
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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