Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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.
 
DeviceImpella RP and Impella RP with SmartAssist
Generic Nametemporary non-roller type right heart support blood pump
Regulation Number870.4360
ApplicantAbiomed, Inc.
22 cherry hill drive
danvers, MA 01923
PMA NumberP170011
Supplement NumberS036
Date Received12/17/2021
Decision Date03/16/2022
Product Code PYX 
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for an alternative luer to be used in the manufacture of the purge sidearm assembly.
-
-