AngelMed Guardian System
FDA premarket approval P150009/S008 · decided 2022-09-21
Approval details
- PMA number
- P150009
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AngelMed Guardian System
- Generic name
- Acute coronary syndrome event detector
- Applicant
- Avertix Medical, Inc.
- Date received
- 2022-08-19
- Decision date
- 2022-09-21
- Days to decision
- 33 days
- Decision code
- APPR
- Product code
- QBI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Eatontown, NJ
- Statement
- Approval for service life expansion to 6 years.
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