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Overview


PMA Pathway—Devices that are permanently implanted into the human body or may be necessary to sustain life and


age of only 1.2 PMAs under review for longer than 180 days in 2012, down from an average of 7.2 just three years prior. In fact, the FDA stopped reporting the number of PMA reviews longer than 180 days as of its October of 2012 listing. Tis change was preceded by a consecutive seven- month period where either one or zero PMAs were beyond the targeted 180-day review period.


Mergers & Acquisitions In terms of the


number of transac- tions, 2012 was an active year with 39 deals announced. Tis


do not have a substantially equivalent device on the market are generally considered Class III devices and are required to pass more stringent hurdles. Receiving a PMA for a device can take several years and cost tens of millions of dollars. Upon approval, how- ever, there are typically considerably fewer competitive devices on the market, making the process potentially quite lucrative. Te number of


PMAs bottomed in 2009, with 15 origi- nal PMAs approved throughout the year. Te following year marked the first increase in year-over- year approvals since 2006, and subsequent increases in 2011 and 2012 returned approv- als to more favorable historical levels. Te FDA has


made great strides in tackling the backlog of reviews, with an aver-


16 Medical Manufacturing 2013


marked the third consecutive year of increased activity, and the highest level seen since 2007. As of December 31, 2012, the 10 largest pure-play medical device companies mentioned at the beginning of the article


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