37751 RECHARGE CHARGING SYSTEM
FDA premarket approval P960009/S142 · decided 2012-04-20
Approval details
- PMA number
- P960009
- Supplement
- S142
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- 37751 RECHARGE CHARGING SYSTEM
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2012-04-04
- Decision date
- 2012-04-20
- Days to decision
- 16 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR LABELING CHANGES TO THE MANUALS FOR THE MODEL 37751 RECHARGE CHARGER SYSTEM, THE INFORMATION FOR PRESCRIBERS MANUAL - MEDTRONIC DBS THERAPY, AND THE INFORMATION FOR PRESCRIBERS MANUAL- MEDTRONIC PAIN THERAPY USING NEUROSTIMULATION FOR CHRONIC PAIN. THESE CHANGES INCLUDE THE ADDITION OF PRECAUTIONS RELATED TO RECHARGER USE, MODIFICATION OF THE DEVICE, AND THE EFFECT OF ELECTROMAGNETIC INTERFERENCE (EMI) ON TELEMETRY COMMUNICATION.
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