PMA P860008S019
- Device
- CARDIOCOMMAND ESOPHAGEAL BIPOLAR PACING & RECORDING CATHETERS
- Applicant
- Cardio Command
- PMA number
- P860008
- Supplement
- S019
- Product code
- LPA
- Decision date
- 2009-08-18
- Classification
- System, Esophageal Pacing
- Generic name
- SYSTEM, ESOPHAGEAL PACING
- Approval order statement
- APPROVAL FOR MODIFICATION OFF THE LABELING TO ENHANCE THE SAFETY IN THE USE OF THE PRODUCTS.
Current openFDA PMA Record#
- Device
- CARDIOCOMMAND ESOPHAGEAL BIPOLAR PACING & RECORDING CATHETERS
- Applicant
- Cardio Command
- PMA number
- P860008
- Supplement
- S019
- Product code
- LPA
- Generic name
- SYSTEM, ESOPHAGEAL PACING
- Decision date
- 2009-08-18
- Decision code
- APPR
- Date received
- 2009-07-06
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFICATION OFF THE LABELING TO ENHANCE THE SAFETY IN THE USE OF THE PRODUCTS.