VARIOUS FAMILIES/MODELS OF PASYS, SPECTRAX, SYMBIOS, & SYNERGYST
FDA premarket approval P820003/S113 · decided 2011-11-17
Approval details
- PMA number
- P820003
- Supplement
- S113
- Supplement type
- Real-Time Process
- Trade name
- VARIOUS FAMILIES/MODELS OF PASYS, SPECTRAX, SYMBIOS, & SYNERGYST
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-09-19
- Decision date
- 2011-11-17
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN UPDATE TO THE OPERATING SYSTEM SOFTWARE FOR THE CARELINK PROGRAMMER ASSOCIATED WITH MEDTRONIC PACEMAKER, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AND CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES APPROVED UNDER THE REFERENCED PMA.
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