PMA P030017S396

Device: WaveWriter Alpha™ and WaveWriter Alpha™ Prime SCS Systems; Celestia and Celestia Prime SCS Systems
Applicant: Boston Scientific Corp
PMA number: P030017
Supplement: S396
Product code: LGW
Decision date: 2026-09-09
Classification: Neurology
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: the removal of the precaution statement related to subperception therapy in the “Information for Prescribers” and “Information for Patients” user manuals for the WaveWriter Alpha, WaveWriter Alpha Prime, Celestia, and Celestia Prime Spinal Cord Stimulation (SCS) Systems.

Current openFDA PMA Record#

Device: WaveWriter Alpha™ and WaveWriter Alpha™ Prime SCS Systems; Celestia and Celestia Prime SCS Systems
Applicant: Boston Scientific Corp
PMA number: P030017
Supplement: S396
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2026-09-09
Decision code: APPR
Date received: 2026-06-11
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: the removal of the precaution statement related to subperception therapy in the “Information for Prescribers” and “Information for Patients” user manuals for the WaveWriter Alpha, WaveWriter Alpha Prime, Celestia, and Celestia Prime Spinal Cord Stimulation (SCS) Systems.