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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.
 
Trade NameDROMOS S.L. PACING SYSTEM
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable, unipolar, multiprogrammable pulse g
ApplicantBIOTRONIK, GMBH & CO.
PMA NumberP820076
Supplement NumberS021
Date Received04/24/1998
Decision Date11/04/1998
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for pacing system which includes a new single-pass vdd pacing lead, a pulse generator with high atrial sensitivity, and a new software module for use with the pms 1000/1000c programmers. The device, as modified, will be marketed under the trade name dromos sl pacing system swm 1000/f05. B00. U, and three versions of the single-pass lead, models sl/11-bp, sl/13-bp and sl/15-bp. This pacing system is indicated for vdd pacing for patients with a healthy sinus node.
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