Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: VASOSEAL ES AND VHD DEVICES
• Classification Name: device, hemostasis, vascular
• Generic Name: vascular hemostasis device
• Applicant: DATASCOPE CORP.
• PMA Number: P920004
• Supplement Number: S015
• Date Received: 03/12/2001
• Decision Date: 09/20/2001
• Product Code: MGB [ Registered Establishments with MGB ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track
• Supplement Reason: labeling change - instructions
• Expedited Review Granted?: No
• Combination Product: No

Approval Order 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 and vasoseal vhd and the vasseal vhd is indicated for use in sealing the femoral arterial puncture site in patients who have undergone diagnostic and interventional catheterization procedures using an 8 french or smaller procedural sheath and retrograde approach. The vasoseal vhd reduces time to hemostasis, and ambulation in patients who have undergone diagnostic or interventional catheterization procedures. In addition, the vasoseal vhd reduces time to discharge in diagnostic patients. The vasoseal vhd also reduces time to hemostasis in interventional patients, when immediate sheath removal is desired. However, early ambulation in these patients has not been demonstrated.