- Device
- Adapta, Versa, Sensia, IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG,
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S614
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2020-03-02
- Decision code
- APPR
- Date received
- 2019-12-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for firmware updates to the MyCareLink Patient Monitor Models 24950 and 24952.