PMA P970004S242
- Device
- InterStim Therapy System (Urinary)
- Applicant
- Medtronic Neuromodulation
- PMA number
- P970004
- Supplement
- S242
- Product code
- EZW
- Decision date
- 2017-05-25
- Classification
- Stimulator, Electrical, Implantable, For Incontinence
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Approval order statement
- Manufacturing process change to add vapor degreaser cleaning to the build clean process at Medtronic Tempe Campus (MTC).
Current openFDA PMA Record#
- Device
- InterStim Therapy System (Urinary)
- Applicant
- Medtronic Neuromodulation
- PMA number
- P970004
- Supplement
- S242
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Decision date
- 2017-05-25
- Decision code
- OK30
- Date received
- 2017-04-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing process change to add vapor degreaser cleaning to the build clean process at Medtronic Tempe Campus (MTC).