PMA P080025S023
- Device
- INTERSTIM II
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S023
- Product code
- QON
- Decision date
- 2011-12-28
- Classification
- Stimulator, Electrical, Implantable, For Incontinence
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Approval order statement
- UPGRADE AND USE VERSION 6.4 OF THE HYBRID SLANT HANDLER SOFTWARE AT MEDTRONIC¿S HYBRID SUPPLIER.
Current openFDA PMA Record#
- Device
- INTERSTIM II
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S023
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2011-12-28
- Decision code
- OK30
- Date received
- 2011-12-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- UPGRADE AND USE VERSION 6.4 OF THE HYBRID SLANT HANDLER SOFTWARE AT MEDTRONIC¿S HYBRID SUPPLIER.