IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter

Drug-coated Peripheral Transluminal Angioplasty Catheter

FDA Premarket Approval P190008

Pre-market Approval Supplement Details

The in. Pact av paclitaxel-coated pta balloon catheter is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, for the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae with reference vessel diameters of 4 to 12 mm.

DeviceIN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
Classification NameDrug-coated Peripheral Transluminal Angioplasty Catheter
Generic NameDrug-coated Peripheral Transluminal Angioplasty Catheter
ApplicantMedtronic Vascular Inc.
Date Received2019-04-03
Decision Date2019-11-21
PMAP190008
SupplementS
Product CodePRC
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product Yes
Applicant Address Medtronic Vascular Inc. 3576 Unocal Place santa Rosa, CA 95403
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P190008Original Filing

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