STAT-PACE II ESOPHAGEAL PACING SYSTEM
FDA premarket approval P840002/S009 · decided 1997-09-03
Approval details
- PMA number
- P840002
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STAT-PACE II ESOPHAGEAL PACING SYSTEM
- Generic name
- SYSTEM, ESOPHAGEAL PACING
- Applicant
- Cardiocommand, Inc.
- Date received
- 1997-01-21
- Decision date
- 1997-09-03
- Days to decision
- 225 days
- Decision code
- APPR
- Product code
- LPA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tampa, FL
- Statement
- Approval for design and labeling modification to the Tapsystem 2A and the STAT-PACE II Esophageal Pacing Systems.
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