ALTO2 DR MODEL 624 /ALTO2 VR MODEL 625 ICDS
FDA premarket approval P980049/S009 · decided 2003-07-02
Approval details
- PMA number
- P980049
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ALTO2 DR MODEL 624 /ALTO2 VR MODEL 625 ICDS
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2003-05-22
- Decision date
- 2003-07-02
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR DOWN-SIZED VERSIONS OF THE ALTO MODELS DR 614 AND VR 615 IMPLANTABLE CARDIOVERTER DEFIBRILLATOS (ICDS), MODIFICATIONS TO THE ORCHESTRA APPLICATION SOFTWARE, AND THE ADDITION OF SEPARATELY PACKAGED IS-1 AND DF-1 PORT PLUGS. THE ICD DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES ALTO DR MODEL 624 ICD AND ALTO VR MODEL 625, AND ARE INDICATED FOR USE IN PATIENTS WHO ARE AT RISK OF SUDDEN DEATH DUE TO VENTRICULAR ARRHYTHMIAS AND HAVE EXPERIENCED ONE OF THE FOLLOWING SITUATI
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