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

Humanitarian Device Exemption (HDE)
  • 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 supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NameIMPELLA RP SYSTEM
Classification Nameright ventricular bypass (assist) device
Generic Nameright ventricular bypass (assist) device
Applicant
Abiomed, Inc.
22 cherry hill dr.
danvers, MA 01923
HDE NumberH140001
Supplement NumberS007
Date Received12/14/2016
Decision Date02/27/2017
Product Code
OJE[ Registered Establishments with OJE ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for design and manufacturing changes to the inflow cannula of the impella rp catheter.
-
-