VARIOUS FAMILIES OF PACEMAKERS
FDA premarket approval P820003/S079 · decided 2007-05-03
Approval details
- PMA number
- P820003
- Supplement
- S079
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VARIOUS FAMILIES OF PACEMAKERS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2007-03-09
- Decision date
- 2007-05-03
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MEDTRONIC MODEL 9986 DESKTOP BOSS (VERSION 1.6) FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER FOR ALL CURRENTLY APPROVED MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS.
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