|
Device | ANGIO-SEAL VASCULAR CLOSURE DEVICE |
Generic Name | Device, hemostasis, vascular |
Applicant | TERUMO MEDICAL CORPORATION 950 ELKTON BLVD. ELKTON, MD 21921 |
PMA Number | P930038 |
Supplement Number | S076 |
Date Received | 05/07/2015 |
Decision Date | 06/04/2015 |
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 REDUCTION IN THE LOWER SHIPMENT TEMPERATURE LIMIT FOR ANGIO-SEAL PRODUCT TRANSPORTATION TO AND FROM THE STERILIZER. |