- Device
- Adapta IPG, Versa IPG, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR M
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S625
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2020-05-04
- Decision code
- OK30
- Date received
- 2020-04-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the manufacturing inspection methods and manufacturing inspection specifications for the connector preparation process.