MEDTRONIC MODEL 2490E CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR MAXIMO DR/VR, MODELS 7278 & 7232 AND INSYNC II
FDA premarket approval P010031/S011 · decided 2003-12-29
Approval details
- PMA number
- P010031
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC MODEL 2490E CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE FOR MAXIMO DR/VR, MODELS 7278 & 7232 AND INSYNC II
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2003-11-28
- Decision date
- 2003-12-29
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- NIK
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.