FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Device, Hemostasis, Vascular
PMA: P010049
·
Supplement: S009
·
Decision Dec 23, 2003
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Device, Hemostasis, Vascular
- Trade Name
- QUICKSEAL CONTROL FEMORAL ARTERIAL CLOSURE SYSTEM
- PMA Number
- P010049
- Supplement Number
- S009
- 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
- December 23, 2003
- Date Received
- October 2, 2003
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL TO REDUCE THE MINIMUM REQUIRED ACCESS SITE DEPTH FROM 3 CENTIMETERS TO 2 CENTIMETERS IN THE INSTRUCTIONS FOR USE.
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 |