DiamondTemp Ablation Catheters

FDA Premarket Approval P200028 S011

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

DeviceDiamondTemp Ablation Catheters
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
ApplicantMedtronic Inc.8200 Coral Sea Streetmounds View, MN 55112 PMA NumberP200028 Supplement NumberS011 Date Received05/16/2022 Decision Date06/15/2022 Product Code OAE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-05-16
Decision Date2022-06-15
PMAP200028
SupplementS011
Product CodeOAE 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressMedtronic Inc.
8200 Coral Sea Street
mounds View, MN 55112 PMA NumberP200028 Supplement NumberS011 Date Received05/16/2022 Decision Date06/15/2022 Product Code OAE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
changes To Electrical Tests For The DiamondTemp Ablation Catheters

Supplemental Filings

Supplement NumberDateSupplement Type
P200028Original Filing
S011 2022-05-16 30-day Notice
S010 2022-02-04 30-day Notice
S009
S008
S007 2021-09-27 30-day Notice
S006 2021-04-20 Special (immediate Track)
S005
S004
S003
S002
S001 2021-02-08 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00763000455699 P200028 000
00763000482145 P200028 000
00763000482183 P200028 000
00763000482176 P200028 000
20763000482163 P200028 000
00763000482190 P200028 003
00763000442842 P200028 004
00763000482121 P200028 006
00763000482114 P200028 006
00763000482107 P200028 006
00763000482138 P200028 006

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.