PMA P980035S823
- Device
- Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT SR MRI IPG; Astra
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S823
- Product code
- NVZ
- Decision date
- 2025-10-03
- Classification
- Cardiovascular
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- updates to the medium rate battery manufacturing process
Current openFDA PMA Record#
- Device
- Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT SR MRI IPG; Astra
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S823
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2025-10-03
- Decision code
- OK30
- Date received
- 2025-09-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- updates to the medium rate battery manufacturing process