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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Description Silicone gel-filled breast prosthesis.
Definition Call for pmas to be filed by 7/9/91 per 56 fr 14627 on 4/10/91
Product CodeFTR
Regulation Number 878.3540
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013
5 7 4 2 2 7 6

Device Problems
Implant, removal of 55
Electro-magnetic interference (EMI) 37
Material rupture 35
Rupture, cause unknown 34
Not Applicable 28
Gel leak 9
Patient-device incompatibility 8
No code available 7
Elective replacement 4
Folded 3
Fluid leak 3
Explanted 3
Elective removal 3
Deflation, cause unknown 3
Break 2
Migration of device or device component 2
Leak 2
Device, or device fragments remain in patient 2
No Known Device Problem 2
Degraded 2
Malposition of device 1
Replace 1
Augmentation, loss of 1
Component(s), broken 1
Calcified 1
Decreased pump speed 1
Device Issue 1
Rupture due to trauma 1
Total Device Problems 252

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0


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