SOLETRA AND ITREL II NEUROSTIMULATORS FOR DEEP BRAIN STIMULATION (DBS) SOFTWARE
FDA premarket approval P960009/S025 · decided 2002-10-31
Approval details
- PMA number
- P960009
- Supplement
- S025
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SOLETRA AND ITREL II NEUROSTIMULATORS FOR DEEP BRAIN STIMULATION (DBS) SOFTWARE
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2002-05-10
- Decision date
- 2002-10-31
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE MODEL 8870 N'VISION APPLICATION CARD. THE MODEL 8870 N'VISION APPLICATION CARD IS AN ACCESSORY TO THE SOLETRA AND ITREL II NEUROSTIMULATORS FOR DBS.
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