Superion Indirect Decompression System

FDA Premarket Approval P140004 S027

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

Sterilization site change have been reviewed and are acceptable. All information, including process validation, supports that the procedures meet the requirements of 21 cfr 820.

DeviceSuperion Indirect Decompression System
Generic NameProsthesis, Spinous Process Spacer/plate
ApplicantBoston Scientific Neuromodulation
Date Received2021-12-03
Decision Date2022-02-08
PMAP140004
SupplementS027
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
S029 2022-12-08 30-day Notice
S028 2021-12-03 Real-time Process
S027 2021-12-03 Normal 180 Day Track No User Fee
S026 2021-09-07 30-day Notice
S025 2021-07-30 30-day Notice
S024 2020-08-24 Normal 180 Day Track No User Fee
S023 2020-08-24 30-day Notice
S022
S021 2020-08-24 30-day Notice
S020
S019 2020-07-20 30-day Notice
S018 2020-06-17 Real-time Process
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

NIH GUDID Devices

Device IDPMASupp
00884662000529 P140004 004

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