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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.
 
DeviceImpella Ventricular Support System
Generic NameTemporary non-roller type left heart support blood pump
ApplicantAbiomed, Inc.
22 Cherry Hill Dr.
Danvers, MA 01923
PMA NumberP140003
Supplement NumberS020
Date Received06/06/2017
Decision Date11/01/2017
Product Code OZD 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a new environmentally controlled area at the current manufacturing facility
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