PROTOS PULSE GENERATOR (PROTOS VR AND PROTOS DR) AND B-K00.P.U AND A-K00.0.U PROGRAMMER SOFTWARE
FDA premarket approval P950037/S028 · decided 2002-12-06
Approval details
- PMA number
- P950037
- Supplement
- S028
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROTOS PULSE GENERATOR (PROTOS VR AND PROTOS DR) AND B-K00.P.U AND A-K00.0.U PROGRAMMER SOFTWARE
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Biotronik, Inc.
- Date received
- 2002-11-15
- Decision date
- 2002-12-06
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR 1) THE COMBINATION OF ALL THE FEATURES OF THE PHILOS FAMILY WITH THE CLOSED LOOP STIMULATION (CLS METHOD OF RATE ADAPTIVE PACING; AND 2) THE ADDITION OF THE PROTOS APPLICATION TO THE SWM AND ATA PROGRAMMER SOFTWARE CARTRIDGES, THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROTOS VR AND PROTOS DR; AND SOFTWARE CARTRIDGES B-K00.P.U AND A-K00.0.U, AND IS INDICATED FOR: A) RATE ADAPTIVE PACING WITH THE PROTOS PACING SYSTEM IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROP
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510(k) clearances by this applicant
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