PMA P840002S009
- Device
- STAT-PACE II ESOPHAGEAL PACING SYSTEM
- Applicant
- Cardiocommand, Inc.
- PMA number
- P840002
- Supplement
- S009
- Product code
- LPA
- Decision date
- 1997-09-03
- Classification
- System, Esophageal Pacing
- Generic name
- SYSTEM, ESOPHAGEAL PACING
- Approval order statement
- Approval for design and labeling modification to the Tapsystem 2A and the STAT-PACE II Esophageal Pacing Systems.
Current openFDA PMA Record#
- Device
- STAT-PACE II ESOPHAGEAL PACING SYSTEM
- Applicant
- Cardiocommand, Inc.
- PMA number
- P840002
- Supplement
- S009
- Product code
- LPA
- Generic name
- SYSTEM, ESOPHAGEAL PACING
- Decision date
- 1997-09-03
- Decision code
- APPR
- Date received
- 1997-01-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design and labeling modification to the Tapsystem 2A and the STAT-PACE II Esophageal Pacing Systems.