Attesta MRI, Sphera MRI, Adapta, Versa, Sensia, Advisa, Advisa MRI, EnPulse and Kappa
FDA premarket approval P980035/S561 · decided 2018-10-18
Approval details
- PMA number
- P980035
- Supplement
- S561
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Attesta MRI, Sphera MRI, Adapta, Versa, Sensia, Advisa, Advisa MRI, EnPulse and Kappa
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2018-08-22
- Decision date
- 2018-10-18
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for updates to the remote monitoring systems for Attesta and Sphera MRI SureScan IPG devices.
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