INSYNC FAMILIES OF CRT-ICDS
FDA premarket approval P010031/S032 · decided 2005-12-22
Approval details
- PMA number
- P010031
- Supplement
- S032
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INSYNC FAMILIES OF CRT-ICDS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2005-12-08
- Decision date
- 2005-12-22
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MODEL 9986 DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8 AND 1.5 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.