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Precision, Precision Novi, Precision Spectra, Spectra WaveWriter, Precision Montage, and Precision Montage MRI Spinal Co

FDA premarket approval P030017/S333 · decided 2020-03-17

Approval details

PMA number
P030017
Supplement
S333
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Precision, Precision Novi, Precision Spectra, Spectra WaveWriter, Precision Montage, and Precision Montage MRI Spinal Co
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Applicant
Boston Scientific Corp
Date received
2020-02-20
Decision date
2020-03-17
Days to decision
26 days
Decision code
OK30
Product code
LGW
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
Alternate EO sterilization cycle and upgraded sterilization equipment to sterilize all sterile products and accessories of the SCS Systems.

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510(k) clearances by this applicant

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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