AngelMed Guardian System
FDA premarket approval P150009/S005 · decided 2021-02-17
Approval details
- PMA number
- P150009
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AngelMed Guardian System
- Generic name
- Acute coronary syndrome event detector
- Applicant
- Avertix Medical, Inc.
- Date received
- 2021-01-19
- Decision date
- 2021-02-17
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- QBI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Eatontown, NJ
- Statement
- New component manufacturer for the external patient electronics system.
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