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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDROMOS S.L. PACING SYSTEM
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego, OR 97035
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/material
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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