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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Nameprogrammer, pacemaker
Generic Nametiered therapy implantable defibrillator
Regulation Number870.3700
PMA NumberP880086
Supplement NumberS098
Date Received12/02/2003
Decision Date01/30/2004
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the header design of a currently marketed device. The device, as modified, will be marketed under the trade name verity adx xl vdr model 5456i and is indicated as follows: the verity adx xl vdr model 5456i is indicated for use only with av plus model 1328c or 1358c single-pass in-line quadripolar leads (the verity adx xl vdr pacing system). The verity adx xl vdr pacing system is intended to provide vdd or vddr pacing for patients with a healthy sinus node and av conduction abnormalities. These modes are indicated for patients who need ventricular pacing when adequate atrial rates and adequate intracavitary atrial complexes are present. This includes the presence of complete av block when: a) atrial contribution is needed for hemodynamic benefit, and b) pacemaker syndrome had existed or is anticipated. Additional indications include normal sinus rhythm and normal av conduction in patients who intermittently need ventricular pacing.