ST. JUDE MEDICAL MECHANICAL HEART VALVE

FDA premarket approval P810002/S076 · decided 2011-08-11

Approval details

PMA number

P810002

Supplement

S076

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

ST. JUDE MEDICAL MECHANICAL HEART VALVE

Generic name

HEART-VALVE, MECHANICAL

Applicant

ABBOTT MEDICAL

Date received

2011-06-13

Decision date

2011-08-11

Days to decision

59 days

Decision code

APPR

Product code

LWQ

Advisory committee

Cardiovascular

Expedited review

No

Location

St. Paul, MN

Statement

APPROVAL FOR CHANGES TO THE SPECIFICATION RANGE FOR THE COURSES PER INCH (CPI) AND THICKNESS OF THE PTFE FABRIC USED IN THE CONSTRUCTION OF THE PTFE SEWING CUFF USED WITH THE MASTERS SERIES VALVES, AS WELL AS APPROVAL OF TWO CHANGES INTENDED TO OFFSET THE INCREASE IN THE FORCE REQUIRED FOR VALVE ROTATION (TORQUE) ASSOCIATED WITH THE FABRIC MODIFICATION. THESE PROPOSED CHANGES ARE FOR THE INCREASE IN THE DIAMETER OF THE ROTATION SPRING AND RETAINER ID AND REDUCING THE LOWER LIMIT OF TORQUE FROM 2

510(k) clearances by this applicant