PMA P130021S126

Device: CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Syst
Applicant: Medtronic, Inc.
PMA number: P130021
Supplement: S126
Product code: NPT
Decision date: 2022-11-01
Generic name: Aortic valve, prosthesis, percutaneously delivered
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: CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Syst
Applicant: Medtronic, Inc.
PMA number: P130021
Supplement: S126
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
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.