PMA P980035S737
- Device
- Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR M
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S737
- Product code
- NVZ
- Decision date
- 2023-01-16
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- Updates to the Final Packaging Process to allow manual loading.
Current openFDA PMA Record#
- Device
- Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR M
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S737
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2023-01-16
- Decision code
- OK30
- Date received
- 2023-01-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updates to the Final Packaging Process to allow manual loading.