META DDDR PACEMAKER PULSE GENERATORS MODELS 1256, 1256D, & 1256B (FORMERLY 1256R)
FDA premarket approval P900070/S006 · decided 1996-12-20
Approval details
- PMA number
- P900070
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- META DDDR PACEMAKER PULSE GENERATORS MODELS 1256, 1256D, & 1256B (FORMERLY 1256R)
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- St. Jude Medical, Cardiac Rhythm Management Divisi
- Date received
- 1993-07-01
- Decision date
- 1996-12-20
- Days to decision
- 1268 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE META DDDR PACEMAKER PULSE GENERATORS MODELS 1256, 1256D, & 1256B TO BE MANUFACTURED AT THE MIAMI LAKES, FLORIDA SITE.
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