|
Device | Femoral Introducer Sheath and Hemostasis(FISH) Device |
Generic Name | Device, hemostasis, vascular |
Applicant | MORRIS INNOVATIVE RESEARCH INC 907 W.SECOND ST BLOOMINGTON, IN 47403 |
PMA Number | P050043 |
Supplement Number | S008 |
Date Received | 07/30/2018 |
Decision Date | 09/19/2018 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Replacement of the current laser cutting equipment with a new laser cutting equipment for the SIS patch cutting operation. |