UPDATE 4-Boston Scientific says FDA won't speed ICD review
* Applied to FDA March 15-16 for ICD manufacturing review
* Says FDA usually decides within 30 days of receipt
* Says FDA is not taking steps to expedite the process
* Says "on solid ground financially," will "weather storm"
* WSJ says DOJ, SEC launch investigations
* Shares close up 2.6 percent (Adds information on DOJ, SEC probes, shares)
By Susan Kelly
CHICAGO, March 29 (Reuters) - Boston Scientific Corp (BSX.N), which pulled its implantable heart defibrillators from the U.S. market two weeks ago, indicated on Monday it could be another two weeks before it could begin selling them again.
The company said on March 15 that it was halting sales of seven brands of implantable cardioverter defibrillators and cardiac resynchronization devices after failing to submit the necessary documents to U.S. regulators to get approval for two changes it made to its manufacturing processes.
The Wall Street Journal, citing an internal company memorandum, reported that the Department of Justice and the Securities and Exchange Commission are investigating the recall.
Boston Scientific spokesman Paul Donovan declined to comment on the newspaper's report.
The devices, which are implanted in the chest and deliver electrical pulses to help coordinate heart pumping, represent about 15 percent of the company's sales.
The recall stunned investors, who sent the company's shares tumbling 20 percent.
Boston Scientific said on Monday it made the submissions to the U.S. Food and Drug Administration on March 15 and 16 and expects a decision within 30 days of the agency's receipt of the paperwork, according to a transcript of a conference call with physicians contained in a company filing with the U.S. Securities and Exchange Commission.
The FDA would not expedite the review process, Boston Scientific said.
"It appears we will have to wait our turn in the queue," Boston Scientific Chief Executive Ray Elliott said.
The company reiterated the manufacturing changes posed no risk to patient safety and was not recommending that patients have implanted devices removed.
It elaborated on the nature of the manufacturing changes, which it said met its own quality system requirements. In one case, it did not submit data for a subcomponent provided by a supply vendor.
In the second case, the company said it failed to file the required documentation on a change to the cleaning process for its defibrillator manufacturing line that occurred when it standardized cycle times with its pacemaker line.
Bernstein analyst Derrick Sung said he still believes the company will resolve the matter in four to six weeks from the date of the recall, but noted the stock market is pricing in the possibility it could take one to two months.
"My view is that they get this resolved within the 30-day filing time," Sung said in an interview. "There is a risk that (FDA) will come back after those 30 days and say we need more information. We will delay this further."
Boston Scientific sought to allay physician concerns about its plans to return to the market.
"You should feel confident that Boston Scientific is on solid ground financially. We will weather this storm and will be here to support you and your patients for the long term," Hank Kucheman, the head of Boston Scientific's cardiology business, told physicians on the call.
The recall was the latest in a series of setbacks for the medical device maker, which in recent months has announced a $1.7 billion stent patent settlement with rival Johnson & Johnson (JNJ.N), a major restructuring and job cuts, and two deals with the U.S. Justice Department to resolve long-running probes stemming from the 2006 acquisition of Guidant Corp.
Sung estimated Boston Scientific is losing 3 cents of earnings per share for every month that its ICDs stay off the market, as well as three to five points of market share.
Boston Scientific stock rose 18 cents, or 2.6 percent, to close at $7.19 on the New York Stock Exchange. (Reporting by Susan Kelly; editing by Robert MacMillan, Gerald E. McCormick and Andre Grenon)
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