FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Agent, Injectable, Embolic
PMA: P030004
·
Supplement: S041
·
Decision Apr 9, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Agent, Injectable, Embolic
- Trade Name
- Apollo Onyx Delivery Micro Catheter
- PMA Number
- P030004
- Supplement Number
- S041
- Device Class
- FDA Class 3
- Product Code
- MFE
- Generic Name
- Agent, injectable, embolic
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- April 9, 2026
- Date Received
- March 13, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
approval to replace manually operated components of the 2-Spindle Coil Winder with automated safety features and procedures using the new MCS 3-Spindle coil winder for the Apollo Onyx Delivery Micro Catheter
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 |
|---|---|---|---|
| MFE | Agent, Injectable, Embolic | FDA class 3 | Unknown |