PMA P190008S043

Device: IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Applicant: Medtronic Vascular, Inc.
PMA number: P190008
Supplement: S043
Product code: PRC
Decision date: 2025-07-15
Classification: Cardiovascular
Generic name: Drug-coated peripheral transluminal angioplasty catheter
Approval order statement: transferring the balloon forming process from Medtronic Ireland to Medtronic Mexico for the IN.PACT Admiral DCB and IN.PACT AV DCB

Current openFDA PMA Record#

Device: IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Applicant: Medtronic Vascular, Inc.
PMA number: P190008
Supplement: S043
Product code: PRC
Generic name: Drug-coated peripheral transluminal angioplasty catheter
Decision date: 2025-07-15
Decision code: OK30
Date received: 2025-06-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: transferring the balloon forming process from Medtronic Ireland to Medtronic Mexico for the IN.PACT Admiral DCB and IN.PACT AV DCB