Dromos Dr/Dr-A and Dromos Sr/Sr-B Cardiac Pacing Systems

FDA premarket approval P950037 · implantable pacemaker Pulse-generator

PMA numberP950037

Approval

Applicant
Biotronik, Inc.
Received
November 16, 1995
Decision date
October 11, 1996 (APPR)
Supplements
276, latest August 27, 2026
Product code
DXY – Implantable Pacemaker Pulse-Generator

Official FDA PMA record

Approval order statement

RATE ADAPTIVE PACING WITH THE DROMOS DR AND DROMOS SR PULSE GENERATORS IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY