PMA P970004S351
- Device
- Master InterStim® Therapy System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P970004
- Supplement
- S351
- Product code
- EZW
- Decision date
- 2022-01-13
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Approval order statement
- Use of a new Distribution Center Sorter Tool (DCST) to check unopened active implantable devices returned from customers.
Current openFDA PMA Record#
- Device
- Master InterStim® Therapy System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P970004
- Supplement
- S351
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Decision date
- 2022-01-13
- Decision code
- OK30
- Date received
- 2021-12-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of a new Distribution Center Sorter Tool (DCST) to check unopened active implantable devices returned from customers.