PMA P970004S359
- Device
- InterStim Therapy System (SNS Urinary Neurostimulator Implantable InterStim)
- Applicant
- Medtronic Neuromodulation
- PMA number
- P970004
- Supplement
- S359
- Product code
- EZW
- Decision date
- 2022-04-15
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Approval order statement
- Replacement of degreasing equipment and use of new degreasing solvent.
Current openFDA PMA Record#
- Device
- InterStim Therapy System (SNS Urinary Neurostimulator Implantable InterStim)
- Applicant
- Medtronic Neuromodulation
- PMA number
- P970004
- Supplement
- S359
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Decision date
- 2022-04-15
- Decision code
- OK30
- Date received
- 2022-03-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement of degreasing equipment and use of new degreasing solvent.