INSYNC II PROTECT, INSYNC III MARQUIS,INSYNC MARQUIS, INSYNC MAXIMO ICDS
FDA premarket approval P010031/S386 · decided 2013-09-27
Approval details
- PMA number
- P010031
- Supplement
- S386
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INSYNC II PROTECT, INSYNC III MARQUIS,INSYNC MARQUIS, INSYNC MAXIMO ICDS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-07-08
- Decision date
- 2013-09-27
- Days to decision
- 81 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MYCARELINK PATIENT MONITOR MODELS 24950 (SOFTWARE VERSION R50), 24951 (SOFTWARE VERSION R50.A.1), AND 24955 (SOFTWARE VERSION V29) TO BE USED WITH THE DEVICES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.