ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC STIMULATORS
FDA premarket approval P860008/S011 · decided 1992-08-06
Approval details
- PMA number
- P860008
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC STIMULATORS
- Generic name
- SYSTEM, ESOPHAGEAL PACING
- Applicant
- Cardio Command
- Date received
- 1991-06-20
- Decision date
- 1992-08-06
- Days to decision
- 413 days
- Decision code
- APPR
- Product code
- LPA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tampa, FL
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