EXTERNAL PULSE GENERATOR MODEL 2A, TAPSCOPE 500 SERIES ESOPHAGEAL STETHOSCOPE AND PACING CATHETER, TAPSCOPE 210 ESOPHAGR
FDA premarket approval P840002/S012 · decided 2004-08-27
Approval details
- PMA number
- P840002
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EXTERNAL PULSE GENERATOR MODEL 2A, TAPSCOPE 500 SERIES ESOPHAGEAL STETHOSCOPE AND PACING CATHETER, TAPSCOPE 210 ESOPHAGR
- Generic name
- SYSTEM, ESOPHAGEAL PACING
- Applicant
- Cardiocommand, Inc.
- Date received
- 2004-06-04
- Decision date
- 2004-08-27
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- LPA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tampa, FL
- Statement
- APPROVAL FOR THE INTERCHANGEABILITY OF EXISTING APPROVED PRODUCTS. THOSE PRODUCTS ARE EXTERNAL PULSE GENERATORS (MODELS 2A, 7A, AND 7B) AND ESOPHAGEAL CATHETER SYSTEMS (MODELS 205, 210, 210S, 1600, 500 SERIES, AND TAPSUL.)
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