8-Channel Adapters
FDA premarket approval P140009/S049 · decided 2019-09-26
Approval details
- PMA number
- P140009
- Supplement
- S049
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 8-Channel Adapters
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- ABBOTT MEDICAL
- Date received
- 2019-07-01
- Decision date
- 2019-09-26
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval for minor packaging design changes to the Torque Wrench and 8-Channel Adapters Kits
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