|
Device | VASOSEAL (VASCULAR HEMOSTASIS DEVICE) |
Generic Name | Device, hemostasis, vascular |
Applicant | St. Jude Medical, Inc. 177 E.COUNTY RD. B EAST ST PAUL, MN 55117 |
PMA Number | P920004 |
Supplement Number | S011 |
Date Received | 10/04/1999 |
Decision Date | 10/22/1999 |
Withdrawal Date
|
12/06/2013 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement The 30-Day Notice proposed a change in the quality cotnrol tests used to delcare sterility of the VasoSeal(R) Needle Depth Indicator Kit. The change will allow for dosimetric release following gamma radiation sterilization in accordance with ANSI/AAMI/ISO 11137-1995 Requirements for validation and routine control - Radiation sterilization. |