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Precision Spinal Cord Stimulator (SCS) Systems

FDA premarket approval P030017/S352 · decided 2022-11-22

Approval details

PMA number
P030017
Supplement
S352
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Precision Spinal Cord Stimulator (SCS) Systems
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Applicant
Boston Scientific Corp
Date received
2022-11-14
Decision date
2022-11-22
Days to decision
8 days
Decision code
OK30
Product code
LGW
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
Add a 6-feet device storage requirement at the Final Pack Automated Test Equipment (ATE) functional test step for Implantable Pulse Generators at the Clonmel Ireland manufacturing site.

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510(k) clearances by this applicant

RecordFirmDate
IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) (K243245)Boston Scientific Corp2024-10-18
LUX-Dx II (M302); LUX-Dx II+ (M312) (K231328)Boston Scientific Corp2023-08-19
WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary (K152853)Boston Scientific Corp2015-11-20
AXIOS Stent with Electrocautery Enhanced Delivery System (K150692)Boston Scientific Corp2015-08-05
XXL Vascular Balloon Dilatation Catheter (K150303)Boston Scientific Corp2015-06-15
Chariot Guiding Sheath (K150186)Boston Scientific Corp2015-06-05
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679)Boston Scientific Corp2015-05-29
JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820)Boston Scientific Corp2014-10-21