PASYS, PASYS ST, SPECTRAX S, SPECTRAX SX, SPECTRAX SX-HT, SPECTRAX SXT, SYSMBIOS, SYNERGYST
FDA premarket approval P820003/S135 · decided 2015-08-17
Approval details
- PMA number
- P820003
- Supplement
- S135
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PASYS, PASYS ST, SPECTRAX S, SPECTRAX SX, SPECTRAX SX-HT, SPECTRAX SXT, SYSMBIOS, SYNERGYST
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-07-02
- Decision date
- 2015-08-17
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN UPDATE TO THE 2090 CARELINK PROGRAMMER DESKTOP SOFTWARE MODEL 9986.
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