1X4 POCKET ADAPTOR KIT, 2X4 POCKET ADAPTOR KIT, ACTIVA SC, KINETRA, SOLETRA, INTERSTIM
FDA premarket approval P960009/S137 · decided 2012-04-12
Approval details
- PMA number
- P960009
- Supplement
- S137
- Supplement type
- 30-Day Notice
- Trade name
- 1X4 POCKET ADAPTOR KIT, 2X4 POCKET ADAPTOR KIT, ACTIVA SC, KINETRA, SOLETRA, INTERSTIM
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2012-03-16
- Decision date
- 2012-04-12
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- ADD TWO ALTERNATE SUPPLIERS FOR THE OUTER SEAL COMPONENT.
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510(k) clearances by this applicant
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