PMA P980035S690
- 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
- S690
- Product code
- NVZ
- Decision date
- 2021-09-08
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- Implement alternate final functional hybrid testing.
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
- S690
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2021-09-08
- Decision code
- OK30
- Date received
- 2021-08-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement alternate final functional hybrid testing.