2490D/E CARELINK MONITORS & MODEL 2491 DDMA SOFTWARE FOR INSYNC MARQUIS & MAXIMO VR/DR CAPABILITY
FDA premarket approval P890003/S073 · decided 2003-12-29
Approval details
- PMA number
- P890003
- Supplement
- S073
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 2490D/E CARELINK MONITORS & MODEL 2491 DDMA SOFTWARE FOR INSYNC MARQUIS & MAXIMO VR/DR CAPABILITY
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 2003-11-28
- Decision date
- 2003-12-29
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MODEL 2490E CARELINK MONITOR AND MODEL 2491 DDMA SOFTWARE TO ALLOW THEIR USE WITH THE MAXIMO DR/VR, MODELS 7278 & 7232 AND INSYNC II MARQUIS, MODEL 7289 DEVICES. THE CARELINK SYSTEM IS INDICATED FOR USE BY A PATIENT TO INTERROGATE THEIR IMPLANTED DEVICE, AND TRANSFER THE DATA TO A PRIVATE, SECURE SERVER BY USE OF A STANDARD (ANALOG) TELEPHONE CONNECTION.
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510(k) clearances by this applicant
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