PMA P190008S042

Device: IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
Applicant: Medtronic Vascular, Inc.
PMA number: P190008
Supplement: S042
Product code: PRC
Decision date: 2025-07-09
Classification: Cardiovascular
Generic name: Drug-coated peripheral transluminal angioplasty catheter
Approval order statement: introduction of an alternate analytical HPLC column for the determination of urea in IN.PACT Admiral and IN.PACT AV paclitaxel coated PTA balloon catheters

Current openFDA PMA Record#

Device: IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
Applicant: Medtronic Vascular, Inc.
PMA number: P190008
Supplement: S042
Product code: PRC
Generic name: Drug-coated peripheral transluminal angioplasty catheter
Decision date: 2025-07-09
Decision code: OK30
Date received: 2025-06-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: introduction of an alternate analytical HPLC column for the determination of urea in IN.PACT Admiral and IN.PACT AV paclitaxel coated PTA balloon catheters