FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Device, Hemostasis, Vascular
PMA: P960043
·
Supplement: S127
·
Decision Dec 9, 2025
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Device, Hemostasis, Vascular
- Trade Name
- Perclose ProGlide® Suture-Mediated Closure System; Prostar® XL Percutaneous Vascular Surgical System
- PMA Number
- P960043
- Supplement Number
- S127
- 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 9, 2025
- Date Received
- May 12, 2025
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
approval for a manufacturing site located at Synergy Health AST, SRL, B13.1 Street 4, Avenue 1, Coyol Free Zone, Coyol, Alajuela, 20102, Costa Rica for sterilization.
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 |