ACTIVARC AND ACTIVAPC
FDA premarket approval P960009/S067 · decided 2009-06-08
Approval details
- PMA number
- P960009
- Supplement
- S067
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACTIVARC AND ACTIVAPC
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- Medtronic, Inc.
- Date received
- 2009-04-15
- Decision date
- 2009-06-08
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR MODEL 64001 (1X4) POCKET ADAPTOR AND MODEL 64002 (2X4) POCKET ADAPTOR.
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