Superion Indirect Decompression System

Prosthesis, Spinous Process Spacer/plate

FDA Premarket Approval P140004 S011

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 of the revised protocol for the post-approval study (pas) protocol.

DeviceSuperion Indirect Decompression System
Classification NameProsthesis, Spinous Process Spacer/plate
Generic NameProsthesis, Spinous Process Spacer/plate
ApplicantVERTIFLEX (R), INCORPORATED
Date Received2017-11-27
Decision Date2018-04-09
PMAP140004
SupplementS011
Product CodeNQO
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Osb
Expedited ReviewNo
Combination Product No
Applicant Address VERTIFLEX (R), INCORPORATED 2714 Loker Avenue West suite 100 carlsbad, CA 92010

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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