PMA P920004S011

Device: VASOSEAL (VASCULAR HEMOSTASIS DEVICE)
Applicant: St. Jude Medical, Inc.
PMA number: P920004
Supplement: S011
Product code: MGB
Decision date: 1999-10-22
Generic name: Device, hemostasis, vascular
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.

Current openFDA PMA Record

Device: VASOSEAL (VASCULAR HEMOSTASIS DEVICE)
Applicant: St. Jude Medical, Inc.
PMA number: P920004
Supplement: S011
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 1999-10-22
Decision code: OK30
Date received: 1999-10-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.