SJM EPIC VALVE AND SJM EPIC SUPRA VALVE

FDA premarket approval P040021/S004 · decided 2007-11-15

Approval details

PMA number

P040021

Supplement

S004

Supplement type

Panel Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

SJM EPIC VALVE AND SJM EPIC SUPRA VALVE

Generic name

replacement Heart-valve

Applicant

ABBOTT MEDICAL

Date received

2006-09-29

Decision date

2007-11-15

Days to decision

412 days

Decision code

APPR

Product code

DYE

Advisory committee

Cardiovascular

Expedited review

No

Location

St. Paul, MN

Statement

APPROVAL FOR THE EPIC VALVE IN AORTIC SIZES 21, 23, 25, 27 AND 29 MM, AND IN MITRAL SIZES 27, 29, 31 AND 33 MM, AND THE SJM EPIC SUPRA VALVE IN AORTIC VALVE SIZES 19, 21, 23, 25 AND 27 MM. THE DEVICE IS INDICATED FOR PATIENTS REQUIRING REPLACEMENT OF A DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE AORTIC AND/OR MITRAL HEART VALVE. IT MAY ALSO BE USED AS A REPLACEMENT FOR A PREVIOUSLY IMPLANTED AORTIC AND/OR MITRAL PROSTHETIC HEART VALVE.

510(k) clearances by this applicant