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 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.
 
DevicePHILOS DR-T PULSE GENERATOR/ICD BELOS VR-T,DR-T,ICD CARDIAC AIRBAG-T
Generic Nameimplantable pacemaker Pulse-generator
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS033
Date Received06/24/2003
Decision Date12/17/2003
Product Codes DTB DXY KRG 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO HOME MONITORING THAT WILL ALLOW PHYSICIANS TO RECEIVE THE IMPLANT DATA VIA THE INTERNET, EMAIL, FAX OR MOBILE PHONE. HOME MONITORING MAY BE USED WITH THE FOLLOWING BIOTRONIK DEVICES: PHILOS DR-T, BELOS DR-T, BELOS VR-T, AND CARDIAC AIRBAG-T.
-
-