FDA PMA Number P210025, SurVeil Drug-Coated Balloon
FDA PMA Number P210025, SurVeil Drug-Coated Balloon
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Contents: PMA dossier of P210025 as redacted copy.
Request Year: 2015
PMA Number: P210025
Device: SurVeil Drug-Coated Balloon
Generic Name: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Manufacturer: Surmodics, Inc.
Product Code: ONU
Date Received: 06/21/2021
Decision Date: 06/16/2023
Notice Date: 07/28/2023
- 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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