• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 PMA to get an up-to-date view of this device.
 
Trade NamePHILOS DR-T PULSE GENERATOR
Classification Nameimplantable pacemaker pulse-generator
Generic Nameexternal dual-chamber pacemaker
Regulation Number870.3610
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS023
Date Received02/11/2002
Decision Date04/02/2002
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the pulse generator to allow transmission of diagnostic information, and for changes to the programmer software. The device, as modified, will be marketed under the trade name philos dr-t pulse generator and b-k00. T. U programmer software, and has the same indications as the currently marketed philos dr. Specifically: 1) rate adaptive pacing with philos dr-t pulse generators is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with physical activity. 2) indications for long-term cardiac pacing include, but are not limited to: sick sinus syndrome (i. E. , bradycardia-tachycardia syndrome, sinus arrest, sinus bradycardia), sino-atrial (sa) block, second- and third-degree av block, and carotid sinus syndrome. 3) patients who demonstrate hemodynamic benefit through maintenance of av synchrony should be considered for one of the dual chamber or atrial pacing modes. Dual chamber modes are specifically indicated for treatment of conduction disorders that require both restoration of rate and av synchrony such as av nodal disease, diminished cardiac output or congestive heart failure associated with conduction disturbances and tachyarrhythmias that are suppressed by chronic pacing.
-
-