PMA P920004S006

Device: VASOSEAL (TM)
Applicant: St. Jude Medical, Inc.
PMA number: P920004
Supplement: S006
Product code: MGB
Decision date: 1997-04-15
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL FOR A CHANGE TO THE INDICATIONS FOR USE TO INCLUDE SUE OF VASOSEAL(R) FOLLOWING STENT IMPLANTATION. THE VASOSEAL(R) VASCULAR HEMOSTASIS DEVICE IS NOW INDICATED FOR USE IN REDUCING TIEM TO HEMOSTASIS AT THE FEMORAL ARTERIAL PUNCTURE SITE AND IN REDUCING TIME TO AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHY, BALLOON ANGIOPLASTY OR STENT PROCEDURES USING AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH AND USING A RETROGRADE APPROACH. THE VASOSEAL(R) VHD IS ALSO INDICATED FOR USE IN REDUCING TIME TO HEMOSTASIS IN BALLOON ANGIOPLASTY AND STENT PATIENTS WHEN IMMEDIATE SHEALTH REMOVAL IS DESIRED. HOWEVER, EARLY AMBULATION IN THESE PATIENTS HAS NOT BEEN DEMONSTRATED.

Current openFDA PMA Record

Device: VASOSEAL (TM)
Applicant: St. Jude Medical, Inc.
PMA number: P920004
Supplement: S006
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 1997-04-15
Decision code: APPR
Date received: 1997-02-25
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A CHANGE TO THE INDICATIONS FOR USE TO INCLUDE SUE OF VASOSEAL(R) FOLLOWING STENT IMPLANTATION. THE VASOSEAL(R) VASCULAR HEMOSTASIS DEVICE IS NOW INDICATED FOR USE IN REDUCING TIEM TO HEMOSTASIS AT THE FEMORAL ARTERIAL PUNCTURE SITE AND IN REDUCING TIME TO AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHY, BALLOON ANGIOPLASTY OR STENT PROCEDURES USING AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH AND USING A RETROGRADE APPROACH. THE VASOSEAL(R) VHD IS ALSO INDICATED FOR USE IN REDUCING TIME TO HEMOSTASIS IN BALLOON ANGIOPLASTY AND STENT PATIENTS WHEN IMMEDIATE SHEALTH REMOVAL IS DESIRED. HOWEVER, EARLY AMBULATION IN THESE PATIENTS HAS NOT BEEN DEMONSTRATED.