PMA P920004S008

Device: VASOSEAL ES DEVICE
Applicant: St. Jude Medical, Inc.
PMA number: P920004
Supplement: S008
Product code: MGB
Decision date: 1998-12-11
Generic name: Device, hemostasis, vascular
Approval order statement: Approval to market a modified version of the VasoSeal(R) Vascular Hemostasis Device. The device, as modified, will be marketed under the trade name VasoSeal(R) Extra Security (ES) Device and is indicated for reducing time to hemostasis at the femoral arterial puncture site and in reducing time to ambulation in patients who have undergone diagnostic angiography or interventional procedures.

Current openFDA PMA Record

Device: VASOSEAL ES DEVICE
Applicant: St. Jude Medical, Inc.
PMA number: P920004
Supplement: S008
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 1998-12-11
Decision code: APPR
Date received: 1997-11-13
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval to market a modified version of the VasoSeal(R) Vascular Hemostasis Device. The device, as modified, will be marketed under the trade name VasoSeal(R) Extra Security (ES) Device and is indicated for reducing time to hemostasis at the femoral arterial puncture site and in reducing time to ambulation in patients who have undergone diagnostic angiography or interventional procedures.