Superion™ Indirect Decompression System (IDS) Kit, Vertiflex Instrument Platform (VIP) Kit

FDA Premarket Approval P140004 S026

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

Distribute the device incorporating the change as requested in this supplement. This change adds an additional supplier for the superion indirect decompression system (ids) instrument kits tray retainer lid. The following manufacturing facility is affected by the change: new supplier:nelipak- mervue, galway, ireland

DeviceSuperion™ Indirect Decompression System (IDS) Kit, Vertiflex Instrument Platform (VIP) Kit
Generic NameProsthesis, Spinous Process Spacer/plate
ApplicantBoston Scientific Neuromodulation
Date Received2021-09-07
Decision Date2021-10-07
PMAP140004
SupplementS026
Product CodeNQO 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess 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
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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