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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
Generic Nameheart-valve, mechanical
Abbott Medical
177 county road b. east
st. paul, MN 55117
PMA NumberP810002
Supplement NumberS101
Date Received06/21/2017
Decision Date03/06/2018
Product Code LWQ 
Advisory Committee Cardiovascular
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.