PMA P030017S249

Device
PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM
Applicant
Boston Scientific Corp
PMA number
P030017
Supplement
S249
Product code
LGW
Decision date
2016-04-01
Classification
Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
Acceptance of an alternate qualified supplier for the Ball Grid Assemblies (BGA) that are used in the Precision Novi Implantable Pulse Generators.
Summary
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Current openFDA PMA Record#

Device
PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM
Applicant
Boston Scientific Corp
PMA number
P030017
Supplement
S249
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2016-04-01
Decision code
OK30
Date received
2016-03-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Acceptance of an alternate qualified supplier for the Ball Grid Assemblies (BGA) that are used in the Precision Novi Implantable Pulse Generators.