PMA P970031S013

Device: FREESTYLE SUBCORONARY BIOPROSTHESIS, MODIFIED SUBCORONARY CONFIGURATION, MODEL 995MS, SIZE 29 MM
Applicant: Medtronic, Inc.
PMA number: P970031
Supplement: S013
Product code: LWR
Decision date: 2003-12-08
Classification: Heart-valve, Non-allograft Tissue
Generic name: heart-valve, non-allograft tissue
Approval order statement: APPROVAL FOR THE FREESTYLE SUBCORONARY BIOPROSTHESIS, MODIFIED SUBCORONARY CONFIGURATION, MODEL 995MS, SIZE 29 MM. THE SUPPLEMENT REQUESTED APPROVAL OF THIS SIZE AS AN ADDITION TO THE EXISTING, APPROVED (OCTOBER 31, 2001, UNDER SUPPLEMENT S010) PRODUCT LINE OF SIZES 19, 21, 23, 25, AND 27 MM. THE DEVICE IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.

Current openFDA PMA Record#

Device: FREESTYLE SUBCORONARY BIOPROSTHESIS, MODIFIED SUBCORONARY CONFIGURATION, MODEL 995MS, SIZE 29 MM
Applicant: Medtronic, Inc.
PMA number: P970031
Supplement: S013
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2003-12-08
Decision code: APPR
Date received: 2003-07-28
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE FREESTYLE SUBCORONARY BIOPROSTHESIS, MODIFIED SUBCORONARY CONFIGURATION, MODEL 995MS, SIZE 29 MM. THE SUPPLEMENT REQUESTED APPROVAL OF THIS SIZE AS AN ADDITION TO THE EXISTING, APPROVED (OCTOBER 31, 2001, UNDER SUPPLEMENT S010) PRODUCT LINE OF SIZES 19, 21, 23, 25, AND 27 MM. THE DEVICE IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC VALVES.