CARDIOCOMMAND ESOPHAGEAL BIPOLAR PACING & RECORDING CATHETERS
FDA premarket approval P860008/S019 · decided 2009-08-18
Approval details
- PMA number
- P860008
- Supplement
- S019
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CARDIOCOMMAND ESOPHAGEAL BIPOLAR PACING & RECORDING CATHETERS
- Generic name
- SYSTEM, ESOPHAGEAL PACING
- Applicant
- Cardio Command
- Date received
- 2009-07-06
- Decision date
- 2009-08-18
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- LPA
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Tampa, FL
- Statement
- APPROVAL FOR MODIFICATION OFF THE LABELING TO ENHANCE THE SAFETY IN THE USE OF THE PRODUCTS.
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