TEMPO FAMILY OF PULSE GENERATORS
FDA premarket approval P900070/S024 · decided 1998-10-29
Approval details
- PMA number
- P900070
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TEMPO FAMILY OF PULSE GENERATORS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- St. Jude Medical, Cardiac Rhythm Management Divisi
- Date received
- 1998-10-06
- Decision date
- 1998-10-29
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for an extension of product shelf life from 12 months to 18 months.
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