PMA P190008S028

Device: IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
Applicant: Medtronic Vascular, Inc.
PMA number: P190008
Supplement: S028
Product code: PRC
Decision date: 2024-04-23
Classification: Cardiovascular
Generic name: Drug-coated peripheral transluminal angioplasty catheter
Approval order statement: Approval for labeling changes to include the final study results of the IN.PACT AV Access IDE Cohort Post Approval Study

Current openFDA PMA Record#

Device: IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
Applicant: Medtronic Vascular, Inc.
PMA number: P190008
Supplement: S028
Product code: PRC
Generic name: Drug-coated peripheral transluminal angioplasty catheter
Decision date: 2024-04-23
Decision code: APPR
Date received: 2023-10-26
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval for labeling changes to include the final study results of the IN.PACT AV Access IDE Cohort Post Approval Study