PMA P980035S821
- Device
- Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG (X1SR01); Az
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S821
- Product code
- NVZ
- Decision date
- 2025-09-05
- Classification
- Cardiovascular
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- implementation of a new visual inspection procedure
Current openFDA PMA Record#
- Device
- Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG (X1SR01); Az
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S821
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2025-09-05
- Decision code
- OK30
- Date received
- 2025-08-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of a new visual inspection procedure