IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter

FDA Premarket Approval P190008 S005

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Updates to the analysis plan and case report forms for the new enrollment in. Pact av access pas

DeviceIN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Generic NameDrug-coated Peripheral Transluminal Angioplasty Catheter
ApplicantMedtronic Vascular Inc.
Date Received2020-08-12
Decision Date2020-09-11
PMAP190008
SupplementS005
Product CodePRC 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
Expedited ReviewNo
Combination Product Yes
Applicant Address Medtronic Vascular Inc. 3576 Unocal Place santa Rosa, CA 95403

Supplemental Filings

Supplement NumberDateSupplement Type
P190008Original Filing
S005 2020-08-12 Normal 180 Day Track No User Fee
S004
S003 2020-05-28 Normal 180 Day Track No User Fee
S002 2020-01-23 30-day Notice
S001

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