|
Device | DUETT PRO SEALING DEVICE AND DIAGNOSTIC DUETT PRO SEALING DEVICE |
Generic Name | Device, hemostasis, vascular |
Applicant | Vascular Solutions, Inc. 6464 SYCAMORE COURT NORTH MINNEAPOLIS, MN 55369 |
PMA Number | P990037 |
Supplement Number | S021 |
Date Received | 06/15/2004 |
Decision Date | 07/14/2004 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MODIFYING THE PRESSURE RELIEF VALVE COMPONENT ON THE CATHETER AND REPLACING THE MIXING 20 GAUGE NEEDLE SYRINGE WITH A NEEDLELESS NON-CORING VIAL ACCESS DEVICE. |