PMA P050043S004

Device: FEMORAL INTRODUCER SHEATH & HEMOSTASIS DEVICE (FISH)
Applicant: Morris Innovative Research, Inc.
PMA number: P050043
Supplement: S004
Product code: MGB
Decision date: 2011-03-17
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL FOR: 1) REPLACING THE SEWN TWO-PIECE SMALL INTESTINE SUBMOCOSA (SIS) ASSEMBLY WITH A SINGLE SIS PIECE; 2) DECREASING THE SIS CUFF LENGTH AND RIBBON WIDTH; 3) MODIFYING THE SIS PATCH TO RELEASE WIRE CONNECTION; AND 4) CHANGING THE SHEATH MATERIAL FROM A HIGH DENSITY POLYETHYLENE (HDPE) TO FLUORINATED ETHYLENE PROPYLENE (FEP).

Current openFDA PMA Record#

Device: FEMORAL INTRODUCER SHEATH & HEMOSTASIS DEVICE (FISH)
Applicant: Morris Innovative Research, Inc.
PMA number: P050043
Supplement: S004
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2011-03-17
Decision code: APPR
Date received: 2011-01-18
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR: 1) REPLACING THE SEWN TWO-PIECE SMALL INTESTINE SUBMOCOSA (SIS) ASSEMBLY WITH A SINGLE SIS PIECE; 2) DECREASING THE SIS CUFF LENGTH AND RIBBON WIDTH; 3) MODIFYING THE SIS PATCH TO RELEASE WIRE CONNECTION; AND 4) CHANGING THE SHEATH MATERIAL FROM A HIGH DENSITY POLYETHYLENE (HDPE) TO FLUORINATED ETHYLENE PROPYLENE (FEP).