Product Code: LWO


Products Classified as LWO

1011Pulse-generator, Single Chamber, Sensor Driven, Implantable

Total Product Life Cycle (TPLC) Devices

1011Pulse-generator, Single Chamber, Sensor Driven, Implantable

FDA Consensus Standards

Pulse-Generator, Single Chamber, Sensor Driven, Implantable [36797]21 CFR Unclassified 🔎
Pulse-Generator, Single Chamber, Sensor Driven, Implantable [37688]21 CFR Unclassified 🔎

Pre-market Approvals for LWO

P030035FRONTIER/FRONTIERII/ANTHEM FAMILY OF CRT-PSSt. Jude Medical, Inc.
P970013MicronySt. Jude Medical, Inc.

Global Unique Device Identification Database

05414734006224Pulse-generator, single chamber, sensor driven, implantable
05415067036384Pulse-generator, single chamber, sensor driven, implantable
05415067034472Pulse-generator, single chamber, sensor driven, implantable
05415067031914Pulse-generator, single chamber, sensor driven, implantable

Maude Adverse Events

2525T MICRONY II, SR+, PKGD/STERST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2020-03-25
2525T MICRONY II, SR+, PKGD/STERABBOTT2020-03-18
LEGENDMDT PUERTO RICO OPERATIONS CO, MED REL2020-02-13
2525T MICRONY II, SR+, PKGD/STERABBOTT2020-02-11
LEGEND IIMDT PUERTO RICO OPERATIONS CO, MED REL2019-10-23
LEGEND IIMDT PUERTO RICO OPERATIONS CO, MED REL2019-06-18
PARADYM 2SORIN GROUP ITALIA S.R.L. - CRM FACILITY2018-07-30
LEGEND IIMDT PUERTO RICO OPERATIONS CO, MED REL2017-12-07
PREVAIL SMEDTRONIC, INC.2017-06-08
PREVAIL SMEDTRONIC, INC.2017-04-06
LEGENDMDT PUERTO RICO OPERATIONS CO, MED REL2016-08-09
PREVAIL SMEDTRONIC OF CANADA2015-10-02
LEGENDMDT PUERTO RICO OPERATIONS CO, MED REL2015-02-10
PREVAIL SMDT PUERTO RICO OPERATIONS CO, MED REL2014-06-10
MINIX STMDT PUERTO RICO OPERATIONS CO, MED REL2014-06-10
LEGEND IIMDT PUERTO RICO OPERATIONS CO, MED REL2014-04-10
LEGEND IIMDT SOFAMOR DANEK PUERTO RICO MFG2013-12-10
MINIXRICE CREEK MFG2013-06-08
MINIXMDT PUERTO RICO OPERATIONS CO, MED REL2013-06-08
MINIXMEDTRONIC CANADA DIST CTR2012-08-13
TRIUMPH VRRICE CREEK MFG2012-02-13
MICRONY II SR+ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION2011-05-11
MEDTRONIC, INC.2008-11-03
DIGISENSOR (FOR ACCUSAT PULSE OXIMETER)DATASCOPE CORPORATION1992-07-09
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