Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Edwards Pacemaker Systems

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K791751 EDWARDS PACEMAKER 30 UNIPOLAR GENERATORDXY1979-09-26 View
510(k) K790452 28 UNIPOLAR AND BIPOLAR PULSE GENERATORSDXY1979-05-08 View
510(k) K781111 LEAD CONVERSION KIT, MODEL 3411978-08-31 View
510(k) K781144 ANALYZER, PACER SYSTEM, PSA-5DTC1978-08-23 View
510(k) K781042 PROLITH 23S PACEMAKERDXY1978-07-27 View
510(k) K780780 MICROPULSE 22S PACEMAKERDXY1978-06-30 View
510(k) K780238 PACEMAKER, PROLITH 23U. PULSE GENERATORDXY1978-03-15 View
510(k) K780091 MICROPULSE 22UDXY1978-01-30 View
510(k) K771987 MICROPULSE 26U PULSE GENERATORDXY1977-11-02 View
510(k) K770656 GENERATOR, PULSE, CARDIAC 20UDXY1977-04-26 View
510(k) K770657 GENERATOR, PULSE, CARDIAC 2LUDXY1977-04-26 View
510(k) K770212 PROLITH MODEL 21S CARDIAC PULSE GEN.DXY1977-03-09 View
510(k) K770211 MICROPULSE MODEL 20SDXY1977-03-07 View
↑