|
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 | S014 |
Date Received | 02/24/2003 |
Decision Date | 03/14/2003 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN ADDITIONAL INCOMING INSPECTION REQUIREMENT TO MEASURE THE OUTER DIAMETER (OD) OF THE DISTAL END OF THE STOPCOCK AND TO TIGHTEN THE TOLERANCE AROUND THE ORIGINALLY APPROVED OD ON THE STOPCOCK DISTAL END. |