Surmodics Provides Regulatory Update on its Strategy to Submit an Amended Premarket Approval Application for the SurVeil™ Drug-Coated Balloon
Surmodics, Inc. (SRDX)
Last surmodics, inc. earnings: 4/29 04:05 pm
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Source: Business Wire
Announces Receipt of Positive Formal FDA Feedback via the Q-Submission ProgramSubstantially reduces the anticipated time and cost needed to receive a PMA EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced that it has received formal feedback from the Food and Drug Administration (FDA; the Agency) related to its proposed approach to submit an amended premarket approval (PMA) application for the SurVeil™ drug-coated balloon (DCB).Following the receipt of the FDA letter announced in the company’s press release on January 19th, Surmodics has been focused on obtaining additional clarification and feedback from the Agency on the pathway and requirements to submit an amended PMA application for the SurVeil DCB in an approvable form. To this end, Surmodics prepared and submitted a Submission Issue Request (SIR), under the FDA’s Q-Submission Program, to ob
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News
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- Investors in Surmodics (NASDAQ:SRDX) have unfortunately lost 54% over the last three years [Yahoo! Finance]Yahoo! Finance
- Surmodics, Inc. (NASDAQ: SRDX) had its "buy" rating re-affirmed by analysts at Needham & Company LLC. They now have a $47.00 price target on the stock.MarketBeat
SRDX
Earnings
- 2/1/24 - Beat
SRDX
Sec Filings
- 2/13/24 - Form SC
- 2/12/24 - Form 8-K
- 2/12/24 - Form 4
- SRDX's page on the SEC website