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 CP with SmartAssist; Impella 2.5/5.0 LD; Impella CP; Impella LD
Generic NameTemporary non-roller type left heart support blood pump
ApplicantABIOMED, INC.
22 CHERRY HILL DR.
DANVERS, MA 01923
PMA NumberP140003
Supplement NumberS037
Date Received07/31/2018
Decision Date08/22/2018
Product Code OZD 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Addition of an alternative biological indicator (BI) for the sterilization of all Impella family of catheters and the adoption of Impella CP with SmartAssist into the existing sterilization cycle for other Impella catheters at an alternate site.
-
-