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 (TM)
• Classification Name: device, hemostasis, vascular
• Generic Name: vascular hemostasis device
• Applicant: DATASCOPE CORP.
• PMA Number: P920004
• Supplement Number: S001
• Date Received: 01/16/1996
• Decision Date: 08/01/1996
• Product Code: MGB [ Registered Establishments with MGB ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track
• Supplement Reason: labeling change - indications
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for the addition of a reduced time to ambulation claim to the indicatios for use.