VARIOUS FAMILIES OF ICDS
FDA premarket approval P900061/S060 · decided 2006-05-12
Approval details
- PMA number
- P900061
- Supplement
- S060
- Supplement type
- Normal 180 Day Track
- 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
- 2005-12-09
- Decision date
- 2006-05-12
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC MODEL 2091 WB WIRELESS PC CARD FOR USE WITH MEDTRONIC MODEL 9986 DESKTOP/BOSS (SW VERSION 1.5) FOR THE MEDTRONIC CARELINK PROGRAMMER (MODEL 2090) FOR ALL MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
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