• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
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.
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
St. Jude Medical, Inc.
one lillehei plaza
st. paul, MN 55117
PMA NumberP810002
Supplement NumberS046
Date Received05/15/1997
Decision Date03/24/1998
Product Code
LWQ[ Registered Establishments with 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 silver to the sewing cuff of the St. Jude Medical Mechanical Heart Valve SJM Masters Series. The device, as modified, will be marketed under the trade name St. Jude Medical Mechanical Heart Valve SJM Masters Series with Silzone Coating and will be available in the following model numbers and sizes: AS-601 and AECS-602 (19, 21, 23, 25, 27, 29, and 31 mm), MS-601 and MECS-602 (19, 21, 23, 25, 27, 29, 31, and 33 mm), and AHPS-605, MHPS-605, AEHPS-606, and MEHPS-606 (17, 19, 21, 23, 25, and 27 mm).