THE SPANNER TEMPORARY PROSTATIC STENT

FDA Premarket Approval P060010 S009

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Minor formulation change in a raw material.

DeviceTHE SPANNER TEMPORARY PROSTATIC STENT
Generic NameStent, Urethral, Prostatic, Semi-permanent
ApplicantSRS MEDICAL
Date Received2011-05-20
Decision Date2011-06-14
PMAP060010
SupplementS009
Product CodeNZC 
Advisory CommitteeGastroenterology/Urology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address SRS MEDICAL 76 Treble Cove Road, #3 north Billerica, MA 01862

Supplemental Filings

Supplement NumberDateSupplement Type
P060010Original Filing
S013 2020-06-22 Panel Track
S012
S011 2013-04-24 Normal 180 Day Track No User Fee
S010 2011-05-20 Real-time Process
S009 2011-05-20 30-day Notice
S008 2009-10-16 Real-time Process
S007 2009-04-28 Real-time Process
S006 2009-04-27 30-day Notice
S005 2009-04-21 Special (immediate Track)
S004 2009-03-16 30-day Notice
S003 2009-01-12 Real-time Process
S002 2008-03-20 30-day Notice
S001 2007-09-20 Normal 180 Day Track

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