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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.
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
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.