PMA P150031S074

Device
Vercise Deep Brain Stimulation (DBS) Systems
Applicant
Boston Scientific Corp
PMA number
P150031
Supplement
S074
Product code
NHL
Decision date
2024-06-21
Classification
Neurology
Generic name
Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement
the qualification of an alternate supplier, Integer, for the Proximal Contact and Distal Electrode components used in Boston Scientific Neuromodulation Spinal Cord Stimulation Leads and Deep Brain Stimulation Lead Extensions

Current openFDA PMA Record#

Device
Vercise Deep Brain Stimulation (DBS) Systems
Applicant
Boston Scientific Corp
PMA number
P150031
Supplement
S074
Product code
NHL
Generic name
Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date
2024-06-21
Decision code
OK30
Date received
2024-05-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
the qualification of an alternate supplier, Integer, for the Proximal Contact and Distal Electrode components used in Boston Scientific Neuromodulation Spinal Cord Stimulation Leads and Deep Brain Stimulation Lead Extensions