|
Device | ANGIOLINK VASCULAR CLOSURE SYSTEM |
Generic Name | Device, hemostasis, vascular |
Applicant | Medtronic Vascular 37A Cherry Hill Drive Danvers, MA 01923 |
PMA Number | P040022 |
Supplement Number | S003 |
Date Received | 03/08/2007 |
Decision Date | 05/24/2007 |
Withdrawal Date
|
10/12/2010 |
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 |
Approval Order Statement APPROVAL FOR INCORPORATION OF THE FOLLOWING PROCESSING AND MATERIAL CHANGES TO THE DISTAL END OF THE VCS 1000 DILATOR: 1) CHANGE IN THE DILATOR MATERIAL FROM NYLON 11 TO PEBAX NYLON 4033 FOR THE DILATOR DISTAL TIP AND FROM NYLON 11 TO PEBAX NYLON 6033 FOR THE DILATOR DISTAL SHAFT; 2) ADDITION OF A RF AND/OR ALTERNATIVE THERMAL ENERGY SOURCE TO BOND THE DILATOR DISTAL TIP TO THE DISTAL SHAFT; AND 3) ADDITION OF A HEAT SHRINK SLEEVE TO ENHANCE THE BOND BETWEEN THE SHAFT AND THE DISTAL TIP. |