MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS

FDA premarket approval P970031/S011 · decided 2001-11-16

Approval details

PMA number

P970031

Supplement

S011

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS

Generic name

heart-valve, non-allograft tissue

Applicant

Medtronic, Inc.

Date received

2001-06-01

Decision date

2001-11-16

Days to decision

168 days

Decision code

APPR

Product code

LWR

Advisory committee

Cardiovascular

Expedited review

No

Location

Santa Ana, CA

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.

510(k) clearances by this applicant