PMA P050043S002

Device: 7F FISH-SP DEVICE
Applicant: Morris Innovative Research, Inc.
PMA number: P050043
Supplement: S002
Product code: MGB
Decision date: 2009-07-24
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
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.

Current openFDA PMA Record#

Device: 7F FISH-SP DEVICE
Applicant: Morris Innovative Research, Inc.
PMA number: P050043
Supplement: S002
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2009-07-24
Decision code: APPR
Date received: 2009-05-26
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
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.