PMA P920004S002

Device: VASOSEAL (TM)
Applicant: St. Jude Medical, Inc.
PMA number: P920004
Supplement: S002
Product code: MGB
Decision date: 1996-08-01
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL FOR A "SPECIAL PMA SUPPLEMENT - CHANGES BEING EFFECTED" AND PROVIDES FOR CHANGES TO THE INSTRUCTIONS FOR USE TO ENHANCE THE SAFETY OF THE USE OF THE DEVICE

Current openFDA PMA Record

Device: VASOSEAL (TM)
Applicant: St. Jude Medical, Inc.
PMA number: P920004
Supplement: S002
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 1996-08-01
Decision code: APPR
Date received: 1996-06-24
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A "SPECIAL PMA SUPPLEMENT - CHANGES BEING EFFECTED" AND PROVIDES FOR CHANGES TO THE INSTRUCTIONS FOR USE TO ENHANCE THE SAFETY OF THE USE OF THE DEVICE