ACTIVA TREMOR CONTROL THERAPY SYSTEM
FDA premarket approval P960009/S016 · decided 2001-08-06
Approval details
- PMA number
- P960009
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACTIVA TREMOR CONTROL THERAPY SYSTEM
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2001-04-16
- Decision date
- 2001-08-06
- Days to decision
- 112 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE MODEL 7495 EXTENSION. THE FICILITY IS LOCATED AT MEDTRONIC NEUROLOGICAL PUERTO RICO OPERATIONS, VILLALBA, PUERTO RICO.
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