PMA P810002S048

Device

ST. JUDE MEDICAL MASTERS SERIES MECHANICAL HEART VALVE

Applicant

ABBOTT MEDICAL

PMA number

P810002

Supplement

S048

Product code

LWQ

Decision date

1999-04-16

Classification

Heart-valve, Mechanical

Generic name

HEART-VALVE, MECHANICAL

Approval order statement

Approval for the addition of 35mm and 37mm mitral valve sizes to the SJM(R) Master Series Mechanical Heart Valve product line (SJM(TM) Master Series with Polyester Cuff, model number MJ-501, and SJM(R) Master Series with Silzone(TM) coating, Polyester Cuff, model number MS-601).

Summary

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