PMA P970031S011

Device: MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
Applicant: Medtronic, Inc.
PMA number: P970031
Supplement: S011
Product code: LWR
Decision date: 2001-11-16
Classification: Heart-valve, Non-allograft Tissue
Generic name: heart-valve, non-allograft tissue
Approval order statement: APPROVAL FOR THE FREESTYLE AORTIC ROOT BIOPROSTHESIS, MODEL 995, SIZE 29 MM; IMPLANTATION TECHNIQUES, SUBCORONARY, FULL-ROOT, AND ROOT INCLUSION. THE SUPPLEMENT REQUESTED APPROVAL OF THIS SIZE AS AN ADDITION TO THE EXISTING, APPROVED PRODUCT LINE OF SIZES 19, 21, 23, 25, AND 27 MM. THE DEVICE IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHESTIC AORTIC VALVES WITH THE OPTION OF AORTIC ROOT REPLACEMENT.

Current openFDA PMA Record#

Device: MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
Applicant: Medtronic, Inc.
PMA number: P970031
Supplement: S011
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2001-11-16
Decision code: APPR
Date received: 2001-06-01
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE FREESTYLE AORTIC ROOT BIOPROSTHESIS, MODEL 995, SIZE 29 MM; IMPLANTATION TECHNIQUES, SUBCORONARY, FULL-ROOT, AND ROOT INCLUSION. THE SUPPLEMENT REQUESTED APPROVAL OF THIS SIZE AS AN ADDITION TO THE EXISTING, APPROVED PRODUCT LINE OF SIZES 19, 21, 23, 25, AND 27 MM. THE DEVICE IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHESTIC AORTIC VALVES WITH THE OPTION OF AORTIC ROOT REPLACEMENT.