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OCT 2 5 W01Premarket Notification Special 510(k) Charger TM PTA Balloon Dilatation Catheters.510(k) Summary Submitter:Boston Scientific Corporation One Sci med Place Maple Grove, MN 55311Contact Person:

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What is charger tm pta balloon?

Charger TM PTA Balloon is a type of medical device used in angioplasty procedures.

Who is required to file charger tm pta balloon?

The manufacturer or distributor of the Charger TM PTA Balloon is required to file the necessary documentation.

How to fill out charger tm pta balloon?

The Charger TM PTA Balloon documentation must be filled out with all relevant information about the device and its intended use.

What is the purpose of charger tm pta balloon?

The purpose of Charger TM PTA Balloon is to treat narrowed or blocked blood vessels in the body.

What information must be reported on charger tm pta balloon?

Information such as the device specifications, intended use, materials used, and relevant testing results must be reported on the Charger TM PTA Balloon documentation.

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