VASOSEAL ES AND VHD DEVICES

FDA premarket approval P920004/S015 · decided 2001-09-20

Approval details

PMA number

P920004

Supplement

S015

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

VASOSEAL ES AND VHD DEVICES

Generic name

Device, hemostasis, vascular

Applicant

St. Jude Medical, Inc.

Date received

2001-03-12

Decision date

2001-09-20

Days to decision

192 days

Decision code

APPR

Product code

MGB

Advisory committee

Cardiovascular

Expedited review

No

Location

St Paul, MN

Statement

APPROVAL TO MODIFY LANGUAGE IN THE INSTRUCTIONS FOR USE (IFU) FOR THE VASOSEAL EA AND VASOSEAL VHD DEVICES TO ADD CLINICAL STUDY DATA TO THE LABELING FOR BOTH DEVICES IN SUPPORT OF A NEW CLAIM FOR REDUCED TIME-TO-DISCHARGE FOR DIAGNOSTIC ANGIOGRAPHY PATIENTS AND TO EXPAND THE INDICATIONS FOR USE FOR THE VASOSEAL VHD DEVICE FROM BALLOON ANGIOPLASTY OR STENT PROCEDURES TO THE GENERAL CATEGORY OF INTERVENTIONAL PROCEDURES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES VASOSEAL ES

510(k) clearances by this applicant