FDA PMA Number P210025, SurVeil Drug-Coated Balloon

FDA PMA Number P210025, SurVeil Drug-Coated Balloon

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Request: 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

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