www.fdanews.com/articles/138749-fda-guidance-recommends-more-stringent-review-of-implantable-pacemakers
FDA Guidance Recommends More Stringent Review of Implantable Pacemakers
July 28, 2011
The FDA unveiled a new draft guidance recommending that Class III implantable pacemaker pulse generators be required to submit premarket approval applications or submit notice of completion of product development protocols.
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