Superion Indirect Decompression System (IDS)

FDA Premarket Approval P140004 S017

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

Approval for a manufacturing site, named synergy health westport, a steris company, located at lodge road, westport, co. Mayo, ireland for sterilization

DeviceSuperion Indirect Decompression System (IDS)
Generic NameProsthesis, Spinous Process Spacer/plate
ApplicantBoston Scientific Neuromodulation
Date Received2020-05-13
Decision Date2020-07-22
PMAP140004
SupplementS017
Product CodeNQO 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Neuromodulation 25155 Rye Canyon Loop valencia, CA 91355

Supplemental Filings

Supplement NumberDateSupplement Type
P140004Original Filing
S017 2020-05-13 Normal 180 Day Track No User Fee
S016 2019-10-08 Real-time Process
S015 2018-06-22 Normal 180 Day Track
S014
S013 2018-03-23 30-day Notice
S012 2017-12-15 Normal 180 Day Track No User Fee
S011 2017-11-27 Normal 180 Day Track No User Fee
S010 2017-11-16 Normal 180 Day Track No User Fee
S009 2017-08-28 Normal 180 Day Track No User Fee
S008 2017-02-21 Normal 180 Day Track No User Fee
S007 2017-01-13 Normal 180 Day Track No User Fee
S006 2017-01-05 Normal 180 Day Track No User Fee
S005 2017-01-05 Normal 180 Day Track
S004 2016-07-25 Normal 180 Day Track
S003 2015-08-13 135 Review Track For 30-day Notice
S002 2015-06-22 Normal 180 Day Track No User Fee
S001 2015-06-22 Normal 180 Day Track No User Fee

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