PMA P980035S838
- Device
- Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Azure S DR MRI IPG; Azure S SR MRI IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S838
- Product code
- NVZ
- Decision date
- 2026-03-27
- Classification
- Cardiovascular
- Generic name
- Pulse generator, permanent, implantable
Current openFDA PMA Record#
- Device
- Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Azure S DR MRI IPG; Azure S SR MRI IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S838
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2026-03-27
- Decision code
- OK30
- Date received
- 2026-03-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier