Device, Hemostasis, Vascular
Basic Information
- Device Name
- Device, Hemostasis, Vascular
- Trade Name
- THE CLOSER AK 6 FR. SMC DEVICE
- PMA Number
- P960043
- Supplement Number
- S039
- Device Class
- FDA Class 3
- Product Code
- MGB
- Generic Name
- Device, hemostasis, vascular
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- May 21, 2002
- Date Received
- April 17, 2002
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR MANUFACTURING AND MATERIAL DESIGN CHANGES, I.E., CHANGING TO A PRESS-FIT HANDLE, TO A GREEN AND WHITE SUTURE, TO AN INTERNAL SUTURE STORAGE, CHANGING THE THUMB CAP/PLUNGER ATTACHMENT BACK TO WHAT WAS PREVIOUSLY APPROVED IN P960043/S036, AND A CHANGE IN THE O-RING MATERIAL. IN ADDITION, THE LABELING IS BEING MODIFIED TO INCLUDE OTHER HEALTHCARE PROFESSIONALS IN THE PRECAUTION ON THE LIMITATION OF USE TO PHYSICIANS WHO HAVE BEEN TRAINED IN THE USE OF THIS DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CLOSER AK 6FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM AND IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5 TO 6 FR. SHEATHS. THE CLOSER 6 FR. SMC SYSTEMS REDUCE THE TIMES TO HEMOSTASIS, AMBULATION (10 FEET) AND DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES WITHOUT COMPLICATING CLINICAL CONDITIONS (REFER TO PRECAUTIONS, SPECIAL PATIENT POPULATIONS).
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MGB | Device, Hemostasis, Vascular | FDA class 3 | Unknown |