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PRECISON SPINAL CORD STIMULATOR (SCS) SYSTEM

FDA premarket approval P030017/S145 · decided 2012-11-19

Approval details

PMA number
P030017
Supplement
S145
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
PRECISON SPINAL CORD STIMULATOR (SCS) SYSTEM
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Applicant
Boston Scientific Corp
Date received
2012-09-27
Decision date
2012-11-19
Days to decision
53 days
Decision code
APPR
Product code
LGW
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
APPROVAL FOR AN UPDATE TO THE CLINICIAN PROGRAMMER COMPUTER USED WITH THE DEVICE. A TABLET COMPUTER FROM ASUS, MODEL EEE SLATE B121, WILL BE USED TO REPLACE THE CURRENT CLINICIAN PROGRAMMER (CP), A TOSHIBA MODEL M400 LAPTOP COMPUTER.

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