ALGOVITA SPINAL CORD STIMULATION SYSTEM
FDA premarket approval P130028/S001 · decided 2015-12-18
Approval details
- PMA number
- P130028
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ALGOVITA SPINAL CORD STIMULATION SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Nuvectra Corporation
- Date received
- 2015-11-27
- Decision date
- 2015-12-18
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Blaine, MN
- Statement
- CHANGE IN SUPPLIER FOR THE LCD MODULE COMPONENT THAT PROVIDES THE PPC TOUCHSCREEN INTERFACE.
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