ALTO 2 DR MODEL 624 AND ALTO 2 VR MODEL 625
FDA premarket approval P980049/S014 · decided 2004-04-15
Approval details
- PMA number
- P980049
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ALTO 2 DR MODEL 624 AND ALTO 2 VR MODEL 625
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2004-02-23
- Decision date
- 2004-04-15
- Days to decision
- 52 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE MODIFICATIONS TO THE ALTO 2 SHOCK MODULE.
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