7F FISH-SP DEVICE
FDA premarket approval P050043/S002 · decided 2009-07-24
Approval details
- PMA number
- P050043
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 7F FISH-SP DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Morris Innovative Research, Inc.
- Date received
- 2009-05-26
- Decision date
- 2009-07-24
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- 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.
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