AngelMed Guardian System
FDA premarket approval P150009/S002 · decided 2021-06-21
Approval details
- PMA number
- P150009
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AngelMed Guardian System
- Generic name
- Acute coronary syndrome event detector
- Applicant
- Avertix Medical, Inc.
- Date received
- 2019-01-28
- Decision date
- 2021-06-21
- Days to decision
- 875 days
- Decision code
- APPR
- Product code
- QBI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Eatontown, NJ
- Statement
- Approval for changes to the design of the Implantable Medical Device resulting in the AMSG3-E model with a 1-year shelf life and a 3-year implanted life.
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