INSYNC SENTRY & MAXIMO USED WITH SOFTWARE APPLICATION, MODELS 7297 AND 7299
FDA premarket approval P010031/S076 · decided 2007-10-04
Approval details
- PMA number
- P010031
- Supplement
- S076
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INSYNC SENTRY & MAXIMO USED WITH SOFTWARE APPLICATION, MODELS 7297 AND 7299
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2007-08-14
- Decision date
- 2007-10-04
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR SOFTWARE AND RAM-WARE MAINTENANCE UPDATES AS WELL AS ASSOCIATED REFERENCE AND IMPLANT MANUAL UPDATES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.