PMA P970004S224
- Device
- InterStim Therapy System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P970004
- Supplement
- S224
- Product code
- EZW
- Decision date
- 2016-09-09
- Classification
- Stimulator, Electrical, Implantable, For Incontinence
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Approval order statement
- Relocation of titanium cleaning and annealing processes from Bodycote to Greatbatch Medical.
Current openFDA PMA Record#
- Device
- InterStim Therapy System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P970004
- Supplement
- S224
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Decision date
- 2016-09-09
- Decision code
- OK30
- Date received
- 2016-08-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocation of titanium cleaning and annealing processes from Bodycote to Greatbatch Medical.