FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Agent, Injectable, Embolic
PMA: P030004
·
Supplement: S028
·
Decision Sep 14, 2021
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Agent, Injectable, Embolic
- Trade Name
- Apollo Onyx Delivery Micro Catheter 1.5 cm, Apollo Onyx Delivery Micro Catheter 3.0 cm
- PMA Number
- P030004
- Supplement Number
- S028
- 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
- September 14, 2021
- Date Received
- September 9, 2021
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Change to add an alternate test equipment for pouch seal tensile testing.
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 |