PMA P180034S002

Device
Tack Endovascular System (6F)
Applicant
Philips Image Guided Therapy Corporation
PMA number
P180034
Supplement
S002
Product code
QCT
Decision date
2020-04-15
Generic name
Scaffold, dissection repair
Approval order statement
Transfer of tube cutting processes to a new site.

Current openFDA PMA Record#

Device
Tack Endovascular System (6F)
Applicant
Philips Image Guided Therapy Corporation
PMA number
P180034
Supplement
S002
Product code
QCT
Generic name
Scaffold, dissection repair
Decision date
2020-04-15
Decision code
OK30
Date received
2020-03-17
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Transfer of tube cutting processes to a new site.