• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


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 NameVARIOUS MODELS OF IPG'S: ACTROS, AXIOS, CYLOS, DROMOS, KAIROS, PHILOS/II, PROTOS, ETC.
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pacemaker pulse generator,pacemaker programmer
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS116
Date Received12/18/2012
Decision Date03/18/2013
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for the ilesto 7/5 vr-t icd, ilesto 7/5 vr-t dx icd, ilesto 7/5 dr-t icd, ilesto 7/5 hft crt-d; iforia 7/5 vr-t icd, iforia 7/5 vr-t dx icd, iforia 7/5 dr-t icd, iforia 7/5 hf-t crt-d; and the psw 1205. U.
Approval Order Approval Order
-
-