MYNXGRIP VASCULAR CLOSURE DEVICE
FDA premarket approval P040044/S056 · decided 2014-07-30
Approval details
- PMA number
- P040044
- Supplement
- S056
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MYNXGRIP VASCULAR CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2014-05-02
- Decision date
- 2014-07-30
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL TO EXPAND THE INDICATIONS FOR USE TO INCLUDE CLOSURE OF VENOUS ACCESS SITES IN ADDITION TO THE CURRENTLY APPROVED USE FOR CLOSURE OF ARTERIAL ACCESS SITES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYNXGRIP VASCULAR CLOSURE DEVICE AND IS INDICATED FOR USE TO SEAL FEMORAL ARTERIAL AND FEMORAL VENOUS ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES UTILIZING A 5F, 6F OR 7
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