|
Device | PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS)SYSTEM |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Boston Scientific Corp. 25155 Rye Canyon Loop Valencia, CA 91355 |
PMA Number | P030017 |
Supplement Number | S236 |
Date Received | 09/11/2015 |
Decision Date | 10/09/2015 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement PROCESS CHANGE TO THE WELDING PROCESS FOR ATTACHING THE BATTERY TO THE KOVAR TABS ON THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) DURING THE MANUFACTURE OF IMPLANTABLE PULSE GENERATOR (IPG) DEVICES. |