PMA P190008S044

Device: IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter
Applicant: Medtronic Vascular, Inc.
PMA number: P190008
Supplement: S044
Product code: PRC
Decision date: 2025-08-12
Classification: Cardiovascular
Generic name: Drug-coated peripheral transluminal angioplasty catheter
Approval order statement: reducing the filter size at the supplier for the Water for Injection (WFI) supplied to Medtronic and used in cleaning the temporary packaging aids (stylets) during the stylet preparation process

Current openFDA PMA Record#

Device: IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter
Applicant: Medtronic Vascular, Inc.
PMA number: P190008
Supplement: S044
Product code: PRC
Generic name: Drug-coated peripheral transluminal angioplasty catheter
Decision date: 2025-08-12
Decision code: OK30
Date received: 2025-07-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: reducing the filter size at the supplier for the Water for Injection (WFI) supplied to Medtronic and used in cleaning the temporary packaging aids (stylets) during the stylet preparation process