TEMPO PULSE GENERATORS
FDA premarket approval P900070/S022 · decided 1998-09-03
Approval details
- PMA number
- P900070
- Supplement
- S022
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TEMPO PULSE GENERATORS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- St. Jude Medical, Cardiac Rhythm Management Divisi
- Date received
- 1998-03-06
- Decision date
- 1998-09-03
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for modifications to the approved labeling including the: addition of a "Cellular Tested" logo and associated language in the Patient and Physician manuals specifying those cellular telephone protocols for which testing has been performed and shown no interaction.
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