• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections

New Search Back to Search Results
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.
Classification Namegraft, vascular, synthetic/biologic composite
Generic Namevascular graft
Regulation Number870.3450
PMA NumberP890045
Supplement NumberS001
Date Received07/08/1993
Decision Date07/05/1995
Product Code
MAL[ Registered Establishments with MAL ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Applying the gelatin coating to the vascusoft, a different substrate graft. The modified device will be marketed under trade name:vascutek gelsoft vascular graft.