PMA P190008S036

Device: IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Applicant: Medtronic Vascular, Inc.
PMA number: P190008
Supplement: S036
Product code: PRC
Decision date: 2025-03-26
Classification: Cardiovascular
Generic name: Drug-coated peripheral transluminal angioplasty catheter
Approval order statement: a change to four of the ingredients of the adhesive used in the manufacture of the IN.PACT Admiral, IN.PACT 018, and IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter header bag pouch.

Current openFDA PMA Record#

Device: IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Applicant: Medtronic Vascular, Inc.
PMA number: P190008
Supplement: S036
Product code: PRC
Generic name: Drug-coated peripheral transluminal angioplasty catheter
Decision date: 2025-03-26
Decision code: APPR
Date received: 2024-11-25
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change to four of the ingredients of the adhesive used in the manufacture of the IN.PACT Admiral, IN.PACT 018, and IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter header bag pouch.