MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM
FDA premarket approval P960009/S154 · decided 2012-09-12
Approval details
- PMA number
- P960009
- Supplement
- S154
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2012-08-14
- Decision date
- 2012-09-12
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- CHANGE THE ACCEPTANCE CRITERIA FOR TITANIUM CONTENT IN THE CABLES AND TO ADD AN ALTERNATE SUPPLIER FOR THE CABLE BRAIDING AND MICRO-EXTRUSION PROCESSES.
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