FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5,6, AND 8 FRENCH

Device, Hemostasis, Vascular

FDA Premarket Approval P050043 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for modification of the sheath. The device, as modified, will be marketed under the trade name fish-sp and is indicated for hemostatic closure of femoral artery access sites. The system is indicated for use in reducing time to hemostasis and time to ambulation in patients who have undergone diagnostic procedures using 5,6, and 8 french procedural sheaths.

DeviceFEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5,6, AND 8 FRENCH
Classification NameDevice, Hemostasis, Vascular
Generic NameDevice, Hemostasis, Vascular
ApplicantMORRIS INNOVATIVE RESEARCH INC
Date Received2008-05-07
Decision Date2008-07-02
PMAP050043
SupplementS001
Product CodeMGB
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address MORRIS INNOVATIVE RESEARCH INC 907 W.second St bloomington, IN 47403

Supplemental Filings

Supplement NumberDateSupplement Type
P050043Original Filing
S008 2018-07-30 30-day Notice
S007
S006 2012-01-13 Real-time Process
S005 2011-05-12 Real-time Process
S004 2011-01-18 Real-time Process
S003
S002 2009-05-26 Real-time Process
S001 2008-05-07 Real-time Process

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