Product Code: LWP


Products Classified as LWP

1012Implantable Pulse Generator, Pacemaker (non-crt)

Total Product Life Cycle (TPLC) Devices

1012Implantable Pulse Generator, Pacemaker (non-crt)

FDA Consensus Standards

Implantable Pulse Generator, Pacemaker (Non-Crt) [36797]21 CFR Unclassified 🔎
Implantable Pulse Generator, Pacemaker (Non-Crt) [36791]21 CFR Unclassified 🔎
Implantable Pulse Generator, Pacemaker (Non-Crt) [37688]21 CFR Unclassified 🔎
Implantable Pulse Generator, Pacemaker (Non-Crt) [36796]21 CFR Unclassified 🔎

Pre-market Approvals for LWP

P820014CORDIS SEQUICOR THETA MODELS 233D & 233ETELECTRONICS PACING SYSTEMS, INC.
P830007GEMINI(R) THETA MODEL 415A CARDIAC PACERTELECTRONICS PACING SYSTEMS, INC.
P940031DISCOVERY/MERIDIAN/PULSAR PACEMAKERSBOSTON SCIENTIFIC
P010012CONTACT RENEWALBoston Scientific Corp.
P880086ACCENT FAMILY OF PACEMAKERSSt. Jude Medical, Inc.
P030054EPIC HF/ATLAS+ HF/PROMOTE FAMILY OF CRT-DSSt. Jude Medical
P030035FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PSSt. Jude Medical, Inc.
P910023CADENCE/CURRENT FAMILY OF ICDSSt. Jude Medical
P960040TELIGEN, INCEPTA, ENERGEN AND PUNCTUA ICD DEVICESBOSTON SCIENTIFIC
P890003ELITE, ELITE II, MINUET, PREVA, PREVA D, PRODIGY, SYNERGYST II, THERA, THERA-I, VITATRON LEGACY, VITATRON LEGACY IIMedtronic, Inc.
P950037ECURO, EFFECTA, ESTELLA, EVIA ENTOVISBIOTRONIK, INC.
P980035ADVISA, ENRHYTHM MRIMEDTRONIC Inc.
P950029REPLY SR, REPLY DR, ESPIRIT SR, ESPIRIT DRMicroPort CRM USA Inc.
P820003SYMBIOS,SYNERGYST IPGSMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
P970012KAPPA 400 DR IPG,KAPPA 400 SR IPGMEDTRONIC Inc.

Global Unique Device Identification Database

00613994763334Implantable pulse generator, pacemaker (non-CRT)
00613994763235Implantable pulse generator, pacemaker (non-CRT)
00613994713650Implantable pulse generator, pacemaker (non-CRT)
00613994521781Implantable pulse generator, pacemaker (non-CRT)
00613994426550Implantable pulse generator, pacemaker (non-CRT)
00613994295040Implantable pulse generator, pacemaker (non-CRT)
00613994222190Implantable pulse generator, pacemaker (non-CRT)
00613994222138Implantable pulse generator, pacemaker (non-CRT)
00613994222114Implantable pulse generator, pacemaker (non-CRT)
00613994222091Implantable pulse generator, pacemaker (non-CRT)
00613994222084Implantable pulse generator, pacemaker (non-CRT)
00613994222046Implantable pulse generator, pacemaker (non-CRT)
00613994177957Implantable pulse generator, pacemaker (non-CRT)
00643169871977Implantable pulse generator, pacemaker (non-CRT)
00643169871939Implantable pulse generator, pacemaker (non-CRT)

Maude Adverse Events

ASSURITY MRIST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-31
ACCOLADE MRI DRBOSTON SCIENTIFIC CORPORATION2020-03-31
ENDURITY MRIST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-31
ASSURITY MRIST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-31
TELIGENBOSTON SCIENTIFIC CORPORATION2020-03-31
ASSURITY MRIST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-31
ENOIMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)MICROPORT CRM S.R.L.2020-03-31
REVO MRI SURESCANMEDTRONIC PUERTO RICO OPERATIONS CO.2020-03-31
ASSURITY MRIST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
ACUITY X4 SPIRAL SBOSTON SCIENTIFIC CORPORATION2020-03-30
ASSURITY MRIST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-30
ACCOLADE EL DRBOSTON SCIENTIFIC CORPORATION2020-03-30
ACCOLADE EL DRBOSTON SCIENTIFIC CORPORATION2020-03-30
ACUITY X4 SPIRAL SBOSTON SCIENTIFIC CORPORATION2020-03-30
ACUITY SPIRALBOSTON SCIENTIFIC CORPORATION2020-03-30
ACCOLADE EL DRBOSTON SCIENTIFIC CORPORATION2020-03-30
ACUITY SPIRALBOSTON SCIENTIFIC CORPORATION2020-03-30
ACCOLADE MRI SRBOSTON SCIENTIFIC CORPORATION2020-03-30
ESSENTIO DRBOSTON SCIENTIFIC CORPORATION2020-03-30
ACCOLADE SRBOSTON SCIENTIFIC CORPORATION2020-03-30
ACCOLADE SRBOSTON SCIENTIFIC CORPORATION2020-03-30
ACCOLADE DRBOSTON SCIENTIFIC CORPORATION2020-03-30
ACCOLADE SRBOSTON SCIENTIFIC CORPORATION2020-03-30
ASSURITY MRIST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
ACUITY X4 STRAIGHTBOSTON SCIENTIFIC CORPORATION2020-03-30
TELIGENBOSTON SCIENTIFIC CORPORATION2020-03-30
ASSURITY MRIST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
ASSURITY MRIST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
ATTAIN LVMPRI2020-03-30
ASSURITY MRIST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
ASSURITY MRIST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
ASSURITY MRIST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
ASSURITY MRIST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
ASSURITY MRIST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-30
ATTAIN OVER THE WIRE LEADMPRI2020-03-29
ASSURITY MRIST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-29
ASSURITY MRIST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-29
ATTAIN BIPOLAR OVER THE WIRE LEADMPRI2020-03-29
ATTAIN OVER THE WIRE LEADMPRI2020-03-29
ATTAIN BIPOLAR OVER THE WIRE LEADMPRI2020-03-29
ATTAIN OVER THE WIRE LEADMPRI2020-03-28
ASSURITY MRIST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-27
ATTAIN BIPOLAR OVER THE WIRE LEADMPRI2020-03-27
ASSURITY MRIST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-27
ASSURITY MRIST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-27
ASSURITY MRIST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-27
ATTAIN BIPOLAR OVER THE WIRE LEADMPRI2020-03-27
ATTAIN OVER THE WIRE LEADMPRI2020-03-27
ASSURITY MRIST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-27
ENDURITY MRI PACEMAKER, SRST. JUDE MEDICAL, INC.(CRM-SYLMAR)2020-03-26

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