FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5,6, AND 8 FRENCH
FDA premarket approval P050043/S001 · decided 2008-07-02
Approval details
- PMA number
- P050043
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5,6, AND 8 FRENCH
- Generic name
- Device, hemostasis, vascular
- Applicant
- Morris Innovative Research, Inc.
- Date received
- 2008-05-07
- Decision date
- 2008-07-02
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- 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.
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