FDA.report

Philips Image Guided Therapy Corporation

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30162573493016257349Philips Image Guided Therapy Corporation1N2026-01-015905 Nathan Lane North Plymouth MN US 55442

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2367451592089172P2300211969-12-31
2367452044557099P160049STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOONONU2017-07-26
2367451669709004K251358Bridge Plus Occlusion Balloon (590-002)MJN2025-06-24
2367452049161027K2115182.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy SystemMCW2021-06-14
2367451285971218K182972Phoenix Atherectomy SystemMCW2018-12-20

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
MCW22021-06-14
MJN12025-06-24
ONU12017-07-26

PMA

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

2022-11-09

Philips 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 TrialsNCT...

Tack Endovascular System (4F)

2022-05-24

Philips Image Guided Therapy Corporation (formerly Intact)5905 Nathan Lane Northplymouth, MN 55442 PMA NumberP190027 Supplement NumberS004 Date Received02/23/2022 Decision Date05/24/2022 Product Code QCT  Advisory Committee Cardiovascular Supplement Typenor...

Tack Endovascular System (6F)

2022-05-24

Philips 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 ...

PMN

Applications

GUDID