Atlas FDA

PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION NOVI SPI

FDA premarket approval P030017/S242 · decided 2015-12-04

Approval details

PMA number
P030017
Supplement
S242
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION NOVI SPI
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Applicant
Boston Scientific Corp
Date received
2015-11-04
Decision date
2015-12-04
Days to decision
30 days
Decision code
OK30
Product code
LGW
Advisory committee
Neurology
Expedited review
No
Location
Valencia, CA
Statement
UPDATES TO THE WELDING SCHEDULE FOR RESISTANCE WELDING OF THE DISTAL END OF SPLITTERS, ADAPTORS, AND LEAD EXTENSIONS.

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