|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||THE CLOSER(TM) AND THE CLOSER S(TM) DEVICES|
|Applicant||ABBOTT VASCULAR INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Reducing the sheath to guide tensile strength acceptance criteria to a minimum of 5 lbf. From 7 lbf.