FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Device, Hemostasis, Vascular
PMA: P050007
·
Supplement: S048
·
Decision Mar 2, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Device, Hemostasis, Vascular
- Trade Name
- StarClose SE Vascular Closure System
- PMA Number
- P050007
- Supplement Number
- S048
- Device Class
- FDA Class 3
- Product Code
- MGB
- Generic Name
- Device, hemostasis, vascular
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- March 2, 2026
- Date Received
- February 2, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
a modification to the sustainable ethylene oxide (SEO) cycle previously approved for Line 1, Line 2, Line 14 and Line 15 at Synergy Health Ireland and implementation of the SEO cycle at Sterigenics Los Angeles
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 |