PMA P190008S034

Device: IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
Applicant: Medtronic Vascular, Inc.
PMA number: P190008
Supplement: S034
Product code: PRC
Decision date: 2024-10-21
Classification: Cardiovascular
Generic name: Drug-coated peripheral transluminal angioplasty catheter
Approval order statement: use of an electronic Manufacturing Execution System (MES) to replace the current paper-based device history record (DHR).

Current openFDA PMA Record#

Device: IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
Applicant: Medtronic Vascular, Inc.
PMA number: P190008
Supplement: S034
Product code: PRC
Generic name: Drug-coated peripheral transluminal angioplasty catheter
Decision date: 2024-10-21
Decision code: OK30
Date received: 2024-10-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: use of an electronic Manufacturing Execution System (MES) to replace the current paper-based device history record (DHR).