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) | Registration & Listing | Adverse Events | Recalls | PMA | 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 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 NameCARDIAC AIRBAG AND BELOS FAMILIES OF ICDS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator
ApplicantBIOTRONIK, INC.
PMA NumberP980023
Supplement NumberS031
Date Received05/15/2008
Decision Date11/04/2008
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of models 500/540 to the lumax family of icd/crt-ds and ics 3000 programmer. These models would contain: ¿ a third programmable cardioversion / defibrillation shock pathway to offer more programming options ¿ automatic threshold measurement (atm) feature ¿ electronic module (hardware) updates to support the third programmable shock path ¿ modifications to the litronik batteries to increase capacity ¿ new standard value of the programmable pacing pulse width ¿ updated ram firmware to support new features.
-
-