ARZCO OCTAPOLAR ESOPHAGEAL PACE & RECORD CATHETER
FDA premarket approval P860008/S010 · decided 1991-05-09
Approval details
- PMA number
- P860008
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ARZCO OCTAPOLAR ESOPHAGEAL PACE & RECORD CATHETER
- Generic name
- SYSTEM, ESOPHAGEAL PACING
- Applicant
- Cardio Command
- Date received
- 1991-02-20
- Decision date
- 1991-05-09
- Days to decision
- 78 days
- Decision code
- APPR
- Product code
- LPA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tampa, FL
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