META DDDR PACING SYSTEM MODEL 1254/FUNC.1250H
FDA premarket approval P900070/S001 · decided 1993-06-29
Approval details
- PMA number
- P900070
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- META DDDR PACING SYSTEM MODEL 1254/FUNC.1250H
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- St. Jude Medical, Cardiac Rhythm Management Divisi
- Date received
- 1992-06-15
- Decision date
- 1993-06-29
- Days to decision
- 379 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
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