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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 Namedevice, hemostasis, vascular
PMA NumberP050043
Supplement NumberS002
Date Received05/26/2009
Decision Date07/24/2009
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the addition of the 7f fish-sp device to the fish product line. The device, as modified, will be marketed under the trade name 7f fish-sp device for closure and is indicated for percutaneous access and closure of the common femoral artery while reducing time to hemostasis, ambulation and time to eligible discharge in patients requiring access of 7f for endovascular procedure with sheath removal.