PMA P180034S004

Device
Tack Endovascular System
Applicant
Philips Image Guided Therapy Corporation
PMA number
P180034
Supplement
S004
Product code
QCT
Decision date
2021-03-16
Generic name
Scaffold, dissection repair
Approval order statement
Alternate supplier for the tip component of the delivery system.

Current openFDA PMA Record#

Device
Tack Endovascular System
Applicant
Philips Image Guided Therapy Corporation
PMA number
P180034
Supplement
S004
Product code
QCT
Generic name
Scaffold, dissection repair
Decision date
2021-03-16
Decision code
OK30
Date received
2021-02-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Alternate supplier for the tip component of the delivery system.