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.
 
DeviceTACHOS DR, TACHOS DR- ATRIAL TX,TACHOS ATX
Generic NameDEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP000009
Supplement NumberS001
Date Received12/13/2000
Decision Date03/05/2001
Product Code MRM 
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 A NEW ICD SYSTEM WHICH INCLUDES THE FOLLOWING: TACHOS DR ICD (MODEL 335572), TACHOS DR TEST HOUSING (MODEL 122068), AND TACHOS DR AND TMS 1000 APPLICATION SOFTWARE I-HDR.0.U (MODEL 334802). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TACHOS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM AND IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTICULAR ARRHYTHMIAS.
-
-