FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5,6, AND 8 FRENCH
FDA premarket approval P050043 · decided 2007-08-20
Approval details
- PMA number
- P050043
- 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
- 2005-11-23
- Decision date
- 2007-08-20
- Days to decision
- 635 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- APPROVAL FOR THE FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5, 6, AND 8 FRENCH. THE DEVICE IS INDICATED AS FOLLOWS: THE FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE IS INTENDED 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, OR 8 FRENCH PROCEDURAL SHEATHS.
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