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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSJM Masters Series Mechanical Heart Valve, 15mm HP
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
Applicant
St. Jude Medical, Inc.
one lillehei plaza
st. paul, MN 55117
PMA NumberP810002
Supplement NumberS101
Date Received06/21/2017
Decision Date03/06/2018
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Clinical Trials NCT02097420
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the 15-mm HP valve, models 15 AHPJ-505 and 15 MHPJ-505, to the Masters Series Mechanical Heart Valve with Hemodynamic Performance Sewing Cuff product line.
Post-Approval StudyShow Report Schedule and Study Progress
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