DBS Extensions
FDA premarket approval P140009/S014 · decided 2016-05-27
Approval details
- PMA number
- P140009
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DBS Extensions
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- ABBOTT MEDICAL
- Date received
- 2016-04-28
- Decision date
- 2016-05-27
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Addition of an alternate supplier of inner tubing and addition of isopropyl alcohol to aid in the assembly of SCS and DBS leads.
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