Tack Endovascular System (4F, 1.5-4.5mm)

FDA Premarket Approval P190027 S005

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

DeviceTack Endovascular System (4F, 1.5-4.5mm)
Generic NameScaffold, Dissection Repair
ApplicantPhilips Image Guided Therapy Corporation (formerly Intact)5905 Nathan Lane Northplymouth, MN 55442 PMA NumberP190027 Supplement NumberS005 Date Received08/29/2022 Decision Date11/09/2022 Product Code QCT  Advisory Committee Cardiovascular Clinical TrialsNCT02942966 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No
Date Received2022-08-29
Decision Date2022-11-09
PMAP190027
SupplementS005
Product CodeQCT 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Pas
Expedited ReviewNo
Combination ProductNo
Applicant AddressPhilips Image Guided Therapy Corporation (formerly Intact)
5905 Nathan Lane North
plymouth, MN 55442 PMA NumberP190027 Supplement NumberS005 Date Received08/29/2022 Decision Date11/09/2022 Product Code QCT  Advisory Committee Cardiovascular Clinical TrialsNCT02942966
Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval For The Post-approval Labeling Update To Include The 36-month Outcomes Of The TOBA II BTK Post-Approval Study.

Supplemental Filings

Supplement NumberDateSupplement Type
P190027Original Filing
S005 2022-08-29 Normal 180 Day Track No User Fee
S004 2022-02-23 Normal 180 Day Track
S003
S002 2021-09-08 30-day Notice
S001 2020-09-01 30-day Notice

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