ALGOVITA SPINAL CORD STIMULATION SYSTEM
FDA premarket approval P130028/S008 · decided 2016-06-22
Approval details
- PMA number
- P130028
- Supplement
- S008
- 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
- 2016-05-24
- Decision date
- 2016-06-22
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Blaine, MN
- Statement
- Use of an alternate polycarbonate/acrylonitrile butadiene styrene (PC/ABS) resin material to manufacture the lower housing of the Trial Cable Interface assembly.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.