- 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
- S629
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2020-07-08
- Decision code
- OK30
- Date received
- 2020-06-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add additional tests to the final functional test program at a BTLE module supplier.