PMA P970031S015

Device: FREESTYLE AORTIC ROOT BIOPROTHESIS MODEL 995
Applicant: Medtronic, Inc.
PMA number: P970031
Supplement: S015
Product code: LWR
Decision date: 2006-08-28
Classification: Heart-valve, Non-allograft Tissue
Generic name: heart-valve, non-allograft tissue
Approval order statement: APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE (IFU) BASED ON THE RESULTS OF THE COMPLETED POST-MARKET STUDY FOR THE DEVICE.

Current openFDA PMA Record#

Device: FREESTYLE AORTIC ROOT BIOPROTHESIS MODEL 995
Applicant: Medtronic, Inc.
PMA number: P970031
Supplement: S015
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2006-08-28
Decision code: APPR
Date received: 2006-03-27
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE (IFU) BASED ON THE RESULTS OF THE COMPLETED POST-MARKET STUDY FOR THE DEVICE.