|
Device | Exablate 4000 System |
Generic Name | MR-guided focused ultrasound system |
Applicant | InSightec 5 NAHUM HETH STREET TIRAT-HACARMET 39120 |
PMA Number | P150038 |
Supplement Number | S007 |
Date Received | 04/23/2018 |
Decision Date | 05/09/2018 |
Product Code |
POH |
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 Consolidate the two connector types of the 1.5T Head Coil cables into a single connector type (P-Type). The change is being made to maintain compatibility with the GE Medical Systems (GE) Signa Artist MR scanner. |