PMA P980035S700
- Device
- Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Azure S DR/SR MRI IPG and Azure XT DR/SR MRI IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S700
- Product code
- NVZ
- Decision date
- 2022-01-18
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- New cleaning basket and transport bin used in manufacturing at Medtronic Tempe Campus.
Current openFDA PMA Record#
- Device
- Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Azure S DR/SR MRI IPG and Azure XT DR/SR MRI IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S700
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2022-01-18
- Decision code
- OK30
- Date received
- 2022-01-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New cleaning basket and transport bin used in manufacturing at Medtronic Tempe Campus.