Infinity Deep Brain Stimulation (DBS) Leads, Extensions and Adapters
FDA premarket approval P140009/S040 · decided 2018-10-03
Approval details
- PMA number
- P140009
- Supplement
- S040
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Infinity Deep Brain Stimulation (DBS) Leads, Extensions and Adapters
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-09-06
- Decision date
- 2018-10-03
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Manufacturing process change that incorporates an automatic test method to measure the inner and outer SCS and DBS tubing.
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