FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Device, Hemostasis, Vascular
PMA: P960043
·
Supplement: S133
·
Decision Apr 17, 2026
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; Perclose ProStyle Suture-Mediated Closure and Repair System
- PMA Number
- P960043
- Supplement Number
- S133
- 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
- April 17, 2026
- Date Received
- March 20, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
implementation of the sustainable ethylene oxide (SEO) cycle in Chamber 1 and Chamber 2 at Sterigenics UK
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 |