TAPCATH AND TAPSCOPE DISPOSABLE TRANSESOPHAGEAL PROBES
FDA premarket approval P860008/S017 · decided 2005-02-03
Approval details
- PMA number
- P860008
- Supplement
- S017
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- TAPCATH AND TAPSCOPE DISPOSABLE TRANSESOPHAGEAL PROBES
- Generic name
- SYSTEM, ESOPHAGEAL PACING
- Applicant
- Cardio Command
- Date received
- 2004-01-16
- Decision date
- 2005-02-03
- Days to decision
- 384 days
- Decision code
- APPR
- Product code
- LPA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tampa, FL
- Statement
- APPROVAL FOR A MANUFACTURING SITE AT CARDIOCOMMAND, INC., TAMPA, FLORIDA.
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