DBS System 4CH Lead / DBS System 8CH Directional Lead
FDA premarket approval P140009/S036 · decided 2018-08-10
Approval details
- PMA number
- P140009
- Supplement
- S036
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DBS System 4CH Lead / DBS System 8CH Directional Lead
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-02-02
- Decision date
- 2018-08-10
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval for updating the primer application step of the parylene coating of the stim tips and term tips from vapor deposition to dipping application.
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