THE ST. JUDE MEDICAL(R) MECHANICAL HEART VALVE SJM(R) MASTERS SERIES

FDA premarket approval P810002/S036 · decided 1995-11-28

Approval details

PMA number

P810002

Supplement

S036

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

THE ST. JUDE MEDICAL(R) MECHANICAL HEART VALVE SJM(R) MASTERS SERIES

Generic name

HEART-VALVE, MECHANICAL

Applicant

ABBOTT MEDICAL

Date received

1995-05-05

Decision date

1995-11-28

Days to decision

207 days

Decision code

APPR

Product code

LWQ

Advisory committee

Cardiovascular

Expedited review

No

Location

St. Paul, MN

Statement

APPROVAL FOR A ROTATABLE VERSION OF THE ST.JUDE MEDICAL MECHANICAL HEART VALVE - THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME:ST. JUDE MEDICAL MASTER SERIES AND WILL BE AVAILABLE IN THE FOLLOWING MODEL NUMBERS AND SIZES:AJ-501 AND AECJ-502 (19, 21, 23, 25, 27, 29, AND 31 MM), MJ-501 AND MECJ-502 (19, 21, 23, 25, 27, 29, 31, AND 33MM) AND AHPJ-505, MHPJ-505, AEJPJ-506, AND MEHPJ-506 (17, 19, 21, 23, 25, AND 27MM). THE SUPPLEMENT ALSO INCLUDES A VALVE HOLDER/ROTATOR ACCESSORY WHICH

510(k) clearances by this applicant