VARIOUS FAMILIES OF ICDS
FDA premarket approval P980016/S063 · decided 2005-12-22
Approval details
- PMA number
- P980016
- Supplement
- S063
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VARIOUS FAMILIES OF ICDS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- 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
- LWS
- 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.
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