- Device
- Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S639
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2020-09-18
- Decision code
- OK30
- Date received
- 2020-08-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of modifications to select manufacturing processes of the backfill hole weld.