PMA P190008S047

Device: IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter
Applicant: Medtronic Vascular, Inc.
PMA number: P190008
Supplement: S047
Product code: PRC
Decision date: 2026-04-23
Classification: Cardiovascular
Generic name: Drug-coated peripheral transluminal angioplasty catheter
Approval order statement: the implementation of an ultraviolet (UV) filter in the water trough system

Current openFDA PMA Record#

Device: IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter
Applicant: Medtronic Vascular, Inc.
PMA number: P190008
Supplement: S047
Product code: PRC
Generic name: Drug-coated peripheral transluminal angioplasty catheter
Decision date: 2026-04-23
Decision code: OK30
Date received: 2026-03-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the implementation of an ultraviolet (UV) filter in the water trough system