VENTRITEX ICD'S
FDA premarket approval P880086/S080 · decided 2000-11-27
Approval details
- PMA number
- P880086
- Supplement
- S080
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTRITEX ICD'S
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 2000-11-02
- Decision date
- 2000-11-27
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR MODEL 3510 PROGRAMMER AND SOFTWARE MODEL 3307 (V2.0).
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