Pacing System Analyzer
QAB is the FDA product code for Pacing System Analyzer, a class II device type, regulated under 21 CFR 870.3605. FDA's definition for this code reads: "The device is intended to supply an accurately calibrated, variable pacing pulse for measuring the patient’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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.
Classification record
- Product code
- QAB
- Device name
- Pacing System Analyzer
- FDA definition
- The device is intended to supply an accurately calibrated, variable pacing pulse for measuring the patient’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.
- Regulation
- 21 CFR 870.3605
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- Yes
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 0
- Ingested recalls
- 0
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code QAB.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.