• 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
 


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.
 
DeviceTECHSTAR XL AND PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEMS
Applicant
ABBOTT VASCULAR INC.
400 saginaw drive
redwood city, CA 94063
PMA NumberP960043
Supplement NumberS008
Date Received06/22/1998
Decision Date07/17/1998
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revised labeling and training materials including, the pvs guidelines for post-procedural care and the training video entitled pvs post procedure care.
-
-