PMA P980035S638
- Device
- Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG,
- Applicant
- Medtronic, Inc.
- Product code
- NVZ
- Decision date
- 2020-11-02
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- Approval for an alternate cellular modem and firmware update to M13.0.
Current openFDA PMA Record#
- Device
- Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG,
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S638
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2020-11-02
- Decision code
- APPR
- Date received
- 2020-08-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an alternate cellular modem and firmware update to M13.0.