PRECISION SPECTRA SPINAL CORD STIMULATION(SCS) SYSTEM
FDA premarket approval P030017/S273 · decided 2017-05-12
Approval details
- PMA number
- P030017
- Supplement
- S273
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PRECISION SPECTRA SPINAL CORD STIMULATION(SCS) SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Boston Scientific Corp
- Date received
- 2016-12-19
- Decision date
- 2017-05-12
- Days to decision
- 144 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for an update to the flash memory component used on the PCBA in the Precision Spectra IPG. The current flash memory component is no longer available and needs to be replaced. The change will replace the current flash memory component with a new flash memory component from the same supplier. The functionality of the IPG is unchanged.
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