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 has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceDIPLOS MODEL 05 A & B
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP820076
Date Received10/12/1982
Decision Date02/15/1984
Withdrawal Date 08/05/2019
Product Code LWP 
Docket Number 84M-0089
Notice Date 04/06/1984
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Supplements: S025  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 S022 S021 
S024 S023 S028 S027 S026 
-
-