PMA P190008S048

Device: IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Applicant: Medtronic Vascular, Inc.
PMA number: P190008
Supplement: S048
Product code: PRC
Decision date: 2026-05-01
Classification: Cardiovascular
Generic name: Drug-coated peripheral transluminal angioplasty catheter
Approval order statement: updates to the luer adhesive curing and balloon forming manufacturing processes

Current openFDA PMA Record#

Device: IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Applicant: Medtronic Vascular, Inc.
PMA number: P190008
Supplement: S048
Product code: PRC
Generic name: Drug-coated peripheral transluminal angioplasty catheter
Decision date: 2026-05-01
Decision code: OK30
Date received: 2026-04-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: updates to the luer adhesive curing and balloon forming manufacturing processes