PMA P150009S013

Device: Guardian System
Applicant: Avertix Medical, Inc.
PMA number: P150009
Supplement: S013
Product code: QBI
Decision date: 2024-06-21
Classification: Cardiovascular
Generic name: Acute coronary syndrome event detector
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P150009

Current openFDA PMA Record#

Device: Guardian System
Applicant: Avertix Medical, Inc.
PMA number: P150009
Supplement: S013
Product code: QBI
Generic name: Acute coronary syndrome event detector
Decision date: 2024-06-21
Decision code: APPR
Date received: 2024-06-14
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P150009