FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Acute Coronary Syndrome Event Detector
PMA: P150009
·
Supplement: S005
·
Decision Feb 17, 2021
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Acute Coronary Syndrome Event Detector
- Trade Name
- AngelMed Guardian System
- PMA Number
- P150009
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- QBI
- Generic Name
- Acute coronary syndrome event detector
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- February 17, 2021
- Date Received
- January 19, 2021
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
New component manufacturer for the external patient electronics system.
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 |
|---|---|---|---|
| QBI | Acute Coronary Syndrome Event Detector | FDA class 3 | Unknown |