Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCelestia Implantable Pulse Generator, Celestia External Trial Stimulator
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantBoston Scientific Corp
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP030017
Supplement NumberS392
Date Received02/09/2026
Decision Date05/21/2026
Product Code LGW 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
-
-