SJM BIOCOR VALVE AND SJM BIOCOR SUPRA VALVE

FDA premarket approval P040021/S003 · decided 2007-05-25

Approval details

PMA number

P040021

Supplement

S003

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

SJM BIOCOR VALVE AND SJM BIOCOR SUPRA VALVE

Generic name

heart-valve, non-allograft tissue

Applicant

ABBOTT MEDICAL

Date received

2006-08-07

Decision date

2007-05-25

Days to decision

291 days

Decision code

APPR

Product code

LWR

Advisory committee

Cardiovascular

Expedited review

No

Location

St. Paul, MN

Statement

APPROVAL FOR THE ADDITION OF THE 29MM BIOCOR AORTIC VALVE; ADDITION OF SIZES 25MM AND 27MM BICOR SUPRA AORTIC VALVE; A CHANGE IN THE PACKAGE SOLUTION CONCENTRATION; A REDUCED PRE-IMPLANT RINSE TIME; A CHANGE IN THE VALE HOLDER AND HOLDER HANDLE DESIGNS; AND ADDITIONAL HEMODYNAMIC DATA FOR THE 27MM BIOCOR MITRAL VALVE.

510(k) clearances by this applicant