PMA P140010S070

Device: IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, IN.PACT 018 Paclitaxel-Coated
Applicant: Medtronic, Inc.
PMA number: P140010
Supplement: S070
Product code: ONU
Decision date: 2022-11-01
Generic name: Drug-Eluting 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 Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, IN.PACT 018 Paclitaxel-Coated
Applicant: Medtronic, Inc.
PMA number: P140010
Supplement: S070
Product code: ONU
Generic name: Drug-Eluting 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.