• 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 NameINTRINSIC 30 DUAL CHAMBER INPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber icds
ApplicantMEDTRONIC VASCULAR
PMA NumberP980016
Supplement NumberS041
Date Received03/04/2004
Decision Date06/25/2004
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the medtronic intrinsic 30 model 7287 dual chamber implantable cardioverter defibrillator (icd) system with model 9996 application software and medtronic intrinsic model 7288 dual chamber implantable cardioverter defibrillator (icd) system with model 9997 application software, which are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.
-
-