Tack Endovascular System (6F)

FDA Premarket Approval P180034 S007

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 (6F)
Generic NameScaffold, Dissection Repair
ApplicantPhilips Image Guided Therapy Corporation5905 Nathan Lane Northplymouth, MN 55442 PMA NumberP180034 Supplement NumberS007 Date Received02/23/2022 Decision Date05/24/2022 Product Code QCT  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-02-23
Decision Date2022-05-24
PMAP180034
SupplementS007
Product CodeQCT 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressPhilips Image Guided Therapy Corporation
5905 Nathan Lane North
plymouth, MN 55442 PMA NumberP180034 Supplement NumberS007 Date Received02/23/2022 Decision Date05/24/2022 Product Code QCT  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement  
a Change Of Quality Management System And Design Ownership From Intact Vascular, Inc. To Philips Image Guided Therapy Corporation

Supplemental Filings

Supplement NumberDateSupplement Type
P180034Original Filing
S007 2022-02-23 Normal 180 Day Track
S006
S005 2021-06-10 Normal 180 Day Track No User Fee
S004 2021-02-23 30-day Notice
S003 2020-09-01 30-day Notice
S002 2020-03-17 30-day Notice
S001 2019-08-02 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00863328000103 P180034 000
00863328000127 P180034 000
00863328000110 P180034 000
00850003494050 P180034 001
00850003494043 P180034 001
00850003494036 P180034 001

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