| 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. |
| |
| Device | ACTROS SLR+,KAIROS SL PULSE GENERATORS;SL 60-11,13,15 BP SINGLE PASS PACING LEAD;SWM 1000 B-G01.0.U |
|---|
| Generic Name | implantable pacemaker Pulse-generator |
|---|
| Regulation Number | 870.3610 |
|---|
| Applicant | BIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035 |
|---|
| PMA Number | P950037 |
|---|
| Supplement Number | S007 |
|---|
| Date Received | 01/20/1999 |
|---|
| Decision Date | 08/04/1999 |
|---|
| Product Code |
DXY |
| Advisory Committee |
Cardiovascular |
|---|
| Supplement Type | Normal 180 Day Track |
|---|
| Supplement Reason | Change Design/Components/Specifications/Material |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
Approval Order Statement
Approval for a VDDR single pass lead system. The device is indicated for the following: The Actros SLR+ and Kairos SL pacemakers are 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 include the presence of complete A-v block when: 1) atrial contribution is needed for hemodynamic benefit; and 2) pacemaker syndrome had existed or is anticipated. Dual chamber modes are specifically indicated for treatment of conduction disorders that require both restoration or 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. Additional indications include: normal sinus rhythm and normal A-V conduction in patients who intermittently need ventricular pacing support. |
|
|
