QAB — Pacing System Analyzer Class II
FDA product code QAB covers "Pacing System Analyzer", a Class II medical device regulated under 21 CFR 870.3605. Submissions are reviewed by the Cardiovascular panel.
Classification Details
- Product Code
- QAB
- Device Class
- Class II
- Regulation Number
- 870.3605
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
The device is intended to supply an accurately calibrated, variable pacing pulse for measuring the patients 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.