• 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.
 
DevicePACEMAKER ICD CRT NON IMPLANTED COMPONENTS
Classification Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Generic Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego, OR 97035
PMA NumberP070008
Supplement NumberS079
Date Received12/07/2016
Decision Date05/04/2017
Product Code
NKE[ Registered Establishments with NKE ]
Advisory Committee Cardiovascular
Clinical Trials NCT02290028
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the Sentus ProMRI OTW QP L/S family of left ventricular pacing leads.
Post-Approval StudyShow Report Schedule and Study Progress
-
-