PMA P960009S008
- Device
- ACTIVA TREMOR CONTROL THERAPY SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S008
- Product code
- MHY
- Decision date
- 1999-12-17
- Classification
- Stimulator, Electrical, Implanted, For Parkinsonian Tremor
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Approval order statement
- Approval for a manufacturing site located at Medtronic Puerto Rico, Villalba, Puerto Rico. The percutaneous extension accessory device (Part #502644-TAB) will be manufactured at this facility.
Current openFDA PMA Record#
- Device
- ACTIVA TREMOR CONTROL THERAPY SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P960009
- Supplement
- S008
- Product code
- MHY
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Decision date
- 1999-12-17
- Decision code
- APPR
- Date received
- 1999-10-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Medtronic Puerto Rico, Villalba, Puerto Rico. The percutaneous extension accessory device (Part #502644-TAB) will be manufactured at this facility.