"This Week Orthopedics" publication:
Walter Eisner • Mon, July 1st, 2013
"The FDA granted five PMA (premarket application) supplemental approvals in April, including two post-approval study protocols......"
"Agency Performance Summary
The agency currently has 50 PMAs under review, with 35 of those on hold. It also has 613 supplementals under review, with 176 of those on hold.
Since the beginning of the year, the agency has approved 51 applications, including supplementals, with an average time of 179 days from receipt of the application to a decision point."
Meanwhile, Augment is at 358 days since second PMA submitted exactly DOUBLE the time and still no approval yet! Next Tuesday marks the one year anniversary to be official!