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PRECISION,PRECISION SPECTRA, PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEMS

FDA premarket approval P030017/S234 · decided 2015-11-12

Approval details

PMA number
P030017
Supplement
S234
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
PRECISION,PRECISION SPECTRA, PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEMS
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Applicant
Boston Scientific Corp
Date received
2015-08-14
Decision date
2015-11-12
Days to decision
90 days
Decision code
APPR
Product code
LGW
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
APPROVAL FOR A MINOR DESIGN CHANGE TO THE PLUG USED IN THE DISTAL TIP OF THE 1X16 INFINION LEADS TO MAKE THE TIP PLUG OF THE 1X16 INFINION LEAD SIMILAR TO THE TIP PLUG OF THE INFINION CX LEAD.

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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
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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