MEDTRONIC MODEL 3625 EXTERNAL TEST STIMULATOR
FDA premarket approval P960009/S108 · decided 2011-04-04
Approval details
- PMA number
- P960009
- Supplement
- S108
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC MODEL 3625 EXTERNAL TEST STIMULATOR
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2011-02-03
- Decision date
- 2011-04-04
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR MINOR DESIGN, MANUFACTURING, AND LABELING CHANGES TO THE MODEL 3625 EXTERNAL TEST STIMULATOR IN ORDER TO ESTABLISH COMPLIANCE WITH FUNCTIONAL REQUIREMENTS IN THE HARMONIZED STANDARDS IEC ((NTERNATIONAL ELECTROTECHNICAL COMMISSION) 60601-1 AND IEC 60601-1-2.
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