- Device
- Celestia Implantable Pulse Generator, Celestia External Trial Stimulator
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S392
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2026-05-21
- Decision code
- APPR
- Date received
- 2026-02-09
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for the firmware of the approved WaveWriter Alpha Implantable Pulse Generators (IPG) and External Trial Stimulator (ETS) to make update to the management of compliance voltage. The Stimulators with the updated firmware will be commercialized under a new brand name “Celestia™”. The IPG, ETS, and Patient Trial Kit will be assigned the following new model numbers: • CelestiaTM 16 Implantable Pulse Generator Kit (SC-1516)• Celestia™ Implantable Pulse Generator Kit (SC-1532)• CelestiaTM Prime 16 Implantable Pulse Generator Kit (SC-1616)• CelestiaTM Prime Implantable Pulse Generator Kit (SC-1632)• CelestiaTM External Trial Stimulator (SC-5177)• Patient Trial Kit (SC-6500-82)Your supplement also requested approval for following minor changes: 1) different device identification marker on the IPG Case and Radiopaque Marker, and orientation of the Radiopaque Marker inside the Case for Celestia IPGs compared to the approved WaveWriter Alpha IPGs, and 2) different model number marked and color of the side panel (from silver to black) of Celestia ETS compared to the approved WaveWriter Alpha ETS. In all other aspects the Celestia™ and Celestia™ Prime IPGs and ETS remain identical to the previously approved WaveWriter Alpha™ and WaveWriter Alpha Prime™ IPGs and ETS including, but not limited to, the hardware, stimulation specifications, dimensions, materials, manufacturing process, manufacturing site, packaging, battery longevity, sterilization, etc.