STAT-PACE II ESOPHAGEAL PACING SYSTEM
FDA premarket approval P840002/S008 · decided 1998-05-07
Approval details
- PMA number
- P840002
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- STAT-PACE II ESOPHAGEAL PACING SYSTEM
- Generic name
- SYSTEM, ESOPHAGEAL PACING
- Applicant
- Cardiocommand, Inc.
- Date received
- 1996-01-03
- Decision date
- 1998-05-07
- Days to decision
- 855 days
- Decision code
- APPR
- Product code
- LPA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tampa, FL
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