Premarket Approval (PMA)

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 Name: PHILOS II DR, PHILOS II D, PHILOS II DR-T, PHILOS II SLR, PHILOS II SR, PHILOS II S, AND PROGRAMMER SOFTWARE VERSION A-U
• Classification Name: implantable pacemaker pulse-generator
• Generic Name: implantable pacemaker pulse generator,pacemaker programmer
• Regulation Number: 870.3610
• Applicant: BIOTRONIK, INC.
• PMA Number: P950037
• Supplement Number: S036
• Date Received: 11/04/2003
• Decision Date: 03/31/2004
• Product Code: DXY [ Registered Establishments with DXY ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track
• Supplement Reason: change design/components/specifications - other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for additional features added to the philos family of pacemakers. The device, as modified, will be marketed under the trade name philos ii and is indicated as follows: rate-adaptive pacing with the philos ii pulse generators is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with physical activity. Generally accepted indications for long-term cardiac pacing include, but are not limited to: sick sinus syndrome (i. E. Bradycardia-tachycardia syndrome, sinus arrest, sinus bradycardia), sino-atrial (sa) block, second- and third- degree av block, and carotid sinus syndrome. Patients who demonstrate hemodynamic benefit through maintenance of av synchrony should be considered for one of the dual chamber or atrial pacing modes. Dual chamber modes are specifically indicated for treatment of conduction disorders that require both restoration of rate and av synchrony such as av nodal disease, diminished cardiac output or congestive heart failure associated with conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing. Philos ii slr pulse generators are primarily 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: 1) atrial contribution is needed for hemodynamic benefit and 2) pacemaker syndrome had existed or is anticipated. Additional indications include normal sinus rhythm and normal av conduction in patients who intermittently need ventricular pacing support.