Adapta, Versa, Sensia IPG, Software application, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG,
FDA premarket approval P980035/S594 · decided 2019-08-20
Approval details
- PMA number
- P980035
- Supplement
- S594
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Adapta, Versa, Sensia IPG, Software application, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG,
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2019-05-22
- Decision date
- 2019-08-20
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for updated RAMware, Application Software, integrated circuit design changes and associated manufacturing tests.
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