|
Device | MARGINPROBE SYSTEM |
Generic Name | Diagnostic low electric field |
Applicant | Dilon Medical Technologies, Ltd. 20 Alon Hatavor Street P.O. Box 3131 Business Park-South 3088900 |
PMA Number | P110014 |
Supplement Number | S004 |
Date Received | 09/23/2014 |
Decision Date | 10/22/2014 |
Product Code |
OEE |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF A TEST JIG AND THE REPLACEMENT OF THE VACUUM PRESSURE REGULATOR COMPONENT. |