ACTIVA PC, ACTIVA SC, ACTIVA RC IMPLANTABLE NEUROSTIMULATORS
FDA premarket approval P960009/S157 · decided 2012-10-10
Approval details
- PMA number
- P960009
- Supplement
- S157
- Supplement type
- 30-Day Notice
- Trade name
- ACTIVA PC, ACTIVA SC, ACTIVA RC IMPLANTABLE NEUROSTIMULATORS
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2012-09-10
- Decision date
- 2012-10-10
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- USE OF THE NEW AUTOMATED ASSEMBLY EQUIPMENT CONTROLLER SOFTWARE RELEASE, INTERFACING WITH THE MANUFACTURING EXECUTION SYSTEM AT THE HYBRID COMPONENT SUPPLIER.
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