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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.
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
8299 central ave., n.e.
spring lake park, MN 55432-3576
PMA NumberP790018
Supplement NumberS032
Date Received01/30/1998
Decision Date07/01/1998
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 to manufacture the sewing ring component of the Medtronic Hall(TM) Prosthetic Heart Valves with knitted polytetrafluoroethylene (PTFE) fabric constructed of PTFE yarn from an alternate supplier. The models affected by the change include Model A7700 (sizes 21, 23, 25, 27, 29, and 31 mm) and Model M7700 (sizes 23, 25, 27, 29, and 31 mm).