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Vasoseal Elite Vhd/Es Device

by St. Jude Medical, Inc.

PMA P920004

Vasoseal Elite Vhd/Es Device is a Class III device made by St. Jude Medical, Inc., approved under FDA PMA P920004 on 29 Sep 1995, withdrawn as of 22 Oct 2026. One FDA recall is linked to it.

Withdrawn Withdrawn in United States.

Was authorized under PMA, withdrawn

Ended

Withdrawn 29 Sep 1995

PMA

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA PMA, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP920004 Date29 Sep 1995Approval withdrawnStatusWithdrawn

Official records

Recalls

1 recall · FDA

    • Terminated Z-0762-04 FDA Unclassified (pre-2012) initiated 28 Jul 2003

    Kits are missing the temporary arteriotomy locator (TAL) from the blister package.

Timeline

2 dated events

  1. Approved FDA PMA P920004
  2. Recall initiated FDA recalls Z-0762-04

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Withdrawn

Specification

PMA

Trade name
Vasoseal (Tm)
Generic name
Device, hemostasis, vascular
PMA number
FDA product code
MGB
Device class
Class III
Advisory committee
Cardiovascular
FDA decision
APWD Approval withdrawn

Similar devices

Other devices filed under FDA product code MGB (Device, Hemostasis, Vascular).

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