FDA warns St. Jude Medical on improper cardiac catheter promotion
May 18, 2010 by MedCity News
The Food & Drug Administration sends a warning letter to St. Jude Medical Inc. citing the device maker for promoting a cardiac ablation catheter system for an unapproved use.
The Food & Drug Administration sent a warning letter to St. Jude Medical Inc. (NYSE:STJ) that cites the device maker for improperly promoting a cardiac ablation catheter system.
St. Jude promoted its Epicor cardiac ablation catheter system on its website for use in treating atrial fibrillation, an irregular heartbeat that can result in stroke. However, the system has only received FDA approval to be used in ablation, or destruction, of diseased heart tissue during surgery.
- Login to post comments
-
Permalink
RECENT BLOG POSTS
- A cure for coffee breath?
- A Goldilocks approach to leaky blood vessels: Not too stiff, but not too loose
- Optimizing electronic medication administration records
- A bold new vision for Meditech
- Medtech storytelling in the era of comparative effectiveness
- Medical device sales: Wright Medical's pilot program on rep-less sales process worth watching
- Raising an early warning in the ICU: T3
- Staff shakeup underway at Russian medical device regulator
- Heart Rhythm Society 2013 Scientific Session wrap-up
- Physician blogger insights on social media
Navigation
NEWS
Pluristem launches Phase I clinical trial to treat tendonitis with stem cells
Pluristem is seeking clinical proof that stem cell therapy can benefit patients with chronic...
GE Healthcare unveils soft tissue imaging technology
GE Healthcare introduces Mavric SL, a novel magnetic resonance imaging technique for joint...
Hip implants: Johnson & Johnson's DePuy will stop selling metal-on-metal implants
Johnson & Johnson subsidiary DePuy Orthopaedics plans to phase out sales of all of its metal-on-...
Combat Medical Systems wins 1st-of-its kind approval for tourniquet
The FDA approves a novel combat-ready clamp to treat wounds most commonly associated with roadside or...
Vascular Solutions CEO: Boston Scientific's alleged patent infringement 'blatant'
Vascular Solutions CEO Howard Root says alleged infringement by Boston Scientific's Guidezilla "is...
