ACTROS SLR+,KAIROS SL PULSE GENERATORS;SL 60-11,13,15 BP SINGLE PASS PACING LEAD;SWM 1000 B-G01.0.U
FDA premarket approval P950037/S007 · decided 1999-08-04
Approval details
- PMA number
- P950037
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 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
- Applicant
- Biotronik, Inc.
- Date received
- 1999-01-20
- Decision date
- 1999-08-04
- Days to decision
- 196 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- 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 be
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510(k) clearances by this applicant
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