Product code QAB
- Device name
- Pacing System Analyzer
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.3605
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- The device is intended to supply an accurately calibrated, variable pacing pulse for measuring the patientÂ’s pacing threshold and intracardiac R-wave potential. A pacing system analyzer (PSA) may be a single, dual, or triple chamber system and can simultaneously deliver pacing therapy while testing one or more implanted pacing leads.
- Source
- FDA openFDA device classification dataset