PMA P970004S164
- Device
- INTERSTIM IMPLANTABLE NEUROSTIMULATOR,INTERSTIM II IMPLANTABLE NEUROSTIMULATOR
- Applicant
- Medtronic Neuromodulation
- PMA number
- P970004
- Supplement
- S164
- Product code
- EZW
- Decision date
- 2013-11-22
- Classification
- Stimulator, Electrical, Implantable, For Incontinence
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Approval order statement
- ADDITION OF A NEW EPOXY MIXER COMPONENT FOR THE MTA EPOXY DISPENSER
Current openFDA PMA Record#
- Device
- INTERSTIM IMPLANTABLE NEUROSTIMULATOR,INTERSTIM II IMPLANTABLE NEUROSTIMULATOR
- Applicant
- Medtronic Neuromodulation
- PMA number
- P970004
- Supplement
- S164
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Decision date
- 2013-11-22
- Decision code
- OK30
- Date received
- 2013-10-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A NEW EPOXY MIXER COMPONENT FOR THE MTA EPOXY DISPENSER