Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | VASCULAR SOLUTIONS DUETT SEALING DEVICE |
Generic Name | Device, hemostasis, vascular |
Applicant | Vascular Solutions, Inc. 6464 SYCAMORE COURT NORTH MINNEAPOLIS, MN 55369 |
PMA Number | P990037 |
Supplement Number | S031 |
Date Received | 07/30/2010 |
Decision Date | 09/15/2010 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIS ISOMEDIX SERVICES, INC., MINNEAPOLIS, MINNESOTA TO PERFORM THE ETHYLENE OXIDE PRE-TREATMENT STEP OF THE BULK COLLAGEN COMPONENT OF THE SUBJECT DEVICE. |
|
|