ALTO 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
FDA premarket approval P980049/S016 · decided 2004-11-17
Approval details
- PMA number
- P980049
- Supplement
- S016
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ALTO 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2004-08-18
- Decision date
- 2004-11-17
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR CHANGES TO THE ALTO 2 ICD LOW-POWER MODULE AND FINAL DEVICE ASSEMBLY PROCESS PERFORMED AT ELA MEDICAL, S.A.
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