MEDTRONIC INSYNC MAXIMO MODEL 7304 AND MODEL 7303
FDA premarket approval P010031/S024 · decided 2005-07-18
Approval details
- PMA number
- P010031
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC INSYNC MAXIMO MODEL 7304 AND MODEL 7303
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2005-06-06
- Decision date
- 2005-07-18
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE CARELINK MONITOR MODEL 2490G FOR USE WITH ADDITIONAL PULSE GENERATOR MODELS, SPECIFICALLY THE INSYNC SENTRY MODEL 7299, INSYNC MAXIMO MODEL 7304, AND THE V-V TIMING FEATURE FOR BOTH THE INSYNC SENTRY MODEL 7297 AND THE INSYNC MAXIMO MODEL 7303. 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.