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U.S. Department of Health and Human Services

Devices@FDA
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Note: if a medical device has supplements, the device description and instructions may have
changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
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239 supplements returned for P030005

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Device Name Company Date Approved Supplement Reason Other Information
crt-p resynchronization devices

supplement #: S222
Guidant Corp. Dec 20, 2022 labeling change - indications/instructions/shelf life/tradename  
cardiac resynchronization therapy - pacemaker (crt-p)

supplement #: S223
Guidant Corp. Dec 12, 2022 process change - manufacturer/sterilizer/packager/supplier  
pg valitude crt-p, pg visionist crt-p

supplement #: S224
Guidant Corp. Oct 28, 2022 process change - manufacturer/sterilizer/packager/supplier  
accolade family of devices pacemakers, and cardiac resynchronization therapy pacemakers (crt-ps)

supplement #: S225
Guidant Corp. Dec 12, 2022 labeling change - indications/instructions/shelf life/tradename  
valitude™ crt-p, valitude™ x4 crt-p, visionist™ crt-p, visionist™ x4 crt-p

supplement #: S226
Guidant Corp. Dec 14, 2022 process change - manufacturer/sterilizer/packager/supplier  
pg valitude crt-p, pg visionist crt-p

supplement #: S227
Guidant Corp. Dec 20, 2022 process change - manufacturer/sterilizer/packager/supplier  
invive, intua, visionist, valitude

supplement #: S228
Guidant Corp. Apr 21, 2023 change design/components/specifications/material  
accolade crt – pacemakers (crt-ps)

supplement #: S229
Guidant Corp. May 11, 2023 process change - manufacturer/sterilizer/packager/supplier  
level viii controlled environment area (cea), level ix cea dry room

supplement #: S230
Guidant Corp. May 01, 2023 process change - manufacturer/sterilizer/packager/supplier  
valitude™ crt-p, valitude™ x4 crt-p, visionist™ crt-p, visionist™ x4 crt-p

supplement #: S231
Guidant Corp. May 08, 2023 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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