Axium Leads and other accessories
FDA premarket approval P150004/S005 · decided 2017-07-03
Approval details
- PMA number
- P150004
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Axium Leads and other accessories
- Generic name
- Dorsal root ganglion stimulator for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2016-10-05
- Decision date
- 2017-07-03
- Days to decision
- 271 days
- Decision code
- APPR
- Product code
- PMP
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval for a manufacturing site located at St. Jude Medical, 6901 Preston Road, Plano, Texas, in which this site will manufacture components of the Axium Spinal Modulation Neurostimulator System.
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