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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search Show TPLC since Back To Search Results
Device prosthesis, penis, inflatable
Regulation Description Penile inflatable implant.
Definition PMAs to be filed by 7/11/00 (65 FR 19658 (4/12/00))
Product CodeJCW
Regulation Number 876.3350
Device Class 3

Premarket Approvals (PMA)
2015 2016 2017 2018 2019 2020
7 11 19 9 20 0

Device Problems
Adverse Event Without Identified Device or Use Problem 1
Total Device Problems 1

Recalls
Manufacturer Recall Class Date Posted
1 American Medical Systems II Jun-25-2015

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