By Paul Citron
Pre-Market Approval (PMA)
FDA releases April PMAs
The Food & Drug Administration released a list of pre-market approvals granted in April:
PMA Original Approvals
Edwards Lifesciences: Sapien heart valve gets July FDA panel date
Edwards Lifesciences Corp. (NYSE:EW) will get its much-anticipated date with the FDA for its flagship Sapien transcatheter heart valve device.
Mela Sciences petitions FDA’s Hamburg on skin cancer device
After nearly two years of waiting for an answer from the FDA on its hand-held biopsy device for skin cancer, Mela Sciences (NSDQ:MELA) is taking to the streets.
FDA approves expanded use for Abbott’s carotid stent | Regulatory roundup
Abbott Laboratories (NYSE:ABT) won aproval from the FDA for expanded use of its RX Acculink carotid stent system.
The expanded indication means the stent system can be used to treat carotid artery disease patients who have a standard risk for complications from carotid endarterectomy surgery, a procedure that entails cutting open a patient’s neck artery and scraping out blockages.
Boston Scientific, Medtronic extend atrial fibrillation treatment offerings with new approvals
Boston Scientific Corp. (NYSE:BSX) and Medtronic Inc. (NYSE:MDT) both announced regulatory approvals for new products that will expand their atrial fibrillation treatment offerings.
Natick, Mass.-based Boston Scientific won CE Mark approval for its Blazer open-irrigated, a radiofrequency ablation (RFA) catheter for treating atrial fibrillation and other arrhythmias.
FDA releases March PMAs
The Food & Drug Administration released a list of pre-market approvals granted in March:
PMA Original Approvals
FDA clears Biomet’s hip implant | Regulatory roundup
Biomet Inc. received FDA 510(k) clearance for its new hip replacement device.
Warsaw, Ind.-based company said its Active Articulation E1 dual mobility hip system is an implant option for orthopedic surgeons performing hip replacement surgery.
FDA approves Boston Scientific’s new Ion drug-eluting stent | Regulatory roundup
Boston Scientific Corp. (NYSE:BSX) is touting the U.S. release of its Ion drug-eluting stent system as the first step toward bolstering its leadership position in the DES market.
The Ion paclitaxel-eluting stent, which is built on Boston Scientific’s next-generation platinum-chromium Element platform, won FDA approval for commercial release in the U.S. The stent, already available in Europe under the Taxus Element label, brought in just under $90 million in sales last quarter.
FDA approves spine sealant from Covidien | Regulatory roundup
Here’s a roundup of companies announcing clearances and approvals from the FDA and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals.
FDA releases February PMAs
The Food & Drug Administration released a list of pre-market approvals granted in February: