PMA P190008S021

Device: IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter
Applicant: Medtronic Vascular, Inc.
PMA number: P190008
Supplement: S021
Product code: PRC
Decision date: 2022-11-01
Generic name: Drug-coated peripheral transluminal angioplasty catheter
Approval order statement: Automation of a verification step undertaken by Sterile Release Personnel (SRP) for Limulus amebocyte lysate (LAL) Bacterial Endotoxin Testing (BET) prior to final release of product.

Current openFDA PMA Record#

Device: IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter
Applicant: Medtronic Vascular, Inc.
PMA number: P190008
Supplement: S021
Product code: PRC
Generic name: Drug-coated peripheral transluminal angioplasty catheter
Decision date: 2022-11-01
Decision code: OK30
Date received: 2022-10-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Automation of a verification step undertaken by Sterile Release Personnel (SRP) for Limulus amebocyte lysate (LAL) Bacterial Endotoxin Testing (BET) prior to final release of product.