1,845 results
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6ms
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Sources: EU EUDAMED, US FDA
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Classification: Class I
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Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·February 20, 2019
Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b) Model Number ATDRL1 (c) Model Number ATDRS1
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·February 20, 2019
Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·February 20, 2019
Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·February 20, 2019
vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model Numbers: G70A1, G70A2 (d) Q-series, Model Numbers: Q50A2, Q70A2, Q80A2
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·February 20, 2019