• 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.
 
DevicePARADYM RF:MODELS VR 9250, DR 9550, CRT-D 9750; PARADYM MODELS VR 8250, DR 8550, CRT-D 8750
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Generic Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Applicant
LivaNova USA, Inc.
100 cyberonics blvd.
houston, TX 77058
PMA NumberP060027
Supplement NumberS053
Date Received08/21/2013
Decision Date03/06/2014
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
APPROVAL FOR:1) A FIRMWARE PATCH FOR THE IMPLANTABLE DEVICE WITH THE MICROPROCESSOR (UP) V4B; 2) A NEW FIRMWARE VERSION FOR THE UP V4C AND V4D; 3) THE HARDWARE MODIFICATIONS FOR THE IMPLANTABLE DEVICES; 4) THE UPDATES/ MODIFICATIONS FOR THE PROGRAMMER APPLICATION SOFTWARE; AND 5) THE UPDATES/ MODIFICATIONS FOR THE REMOTE MONITORING SYSTEM (RMS).
Approval Order Approval Order
-
-