DiamondTemp Ablation System™ with the EnSite™ X Mapping System

FDA Premarket Approval P200028 S012

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 System™ with the EnSite™ X Mapping System
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
ApplicantMedtronic Inc.8200 Coral Sea Streetmounds View, MN 55112 PMA NumberP200028 Supplement NumberS012 Date Received07/15/2022 Decision Date10/12/2022 Product Code OAE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-07-15
Decision Date2022-10-12
PMAP200028
SupplementS012
Product CodeOAE 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressMedtronic Inc.
8200 Coral Sea Street
mounds View, MN 55112 PMA NumberP200028 Supplement NumberS012 Date Received07/15/2022 Decision Date10/12/2022 Product Code OAE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement  
approval For Compatibility Of The DiamondTemp Ablation System With The Abbott EnSite X Mapping And Navigation System

Supplemental Filings

Supplement NumberDateSupplement Type
P200028Original Filing
S014 2022-10-17 Normal 180 Day Track No User Fee
S013
S012 2022-07-15 Real-time Process
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
00763000709136 P200028 000
00763000455699 P200028 000
00763000512255 P200028 000
00763000709198 P200028 000
20763000482163 P200028 000
00763000482176 P200028 000
00763000482183 P200028 000
00763000709150 P200028 000
00763000482145 P200028 000
00763000482190 P200028 003
00763000442842 P200028 004
00763000482107 P200028 006
00763000482114 P200028 006
00763000482121 P200028 006
00763000482138 P200028 006
00763000540616 P200028 009
00763000747121 P200028 012
00763000747114 P200028 012
00763000687960 P200028 013
00763000745516 P200028 016
00763000745509 P200028 016
00763000709174 P200028 018
00763000709181 P200028 018
20763000687988 P200028 018
00763000536688 P200028 020
00763000536671 P200028 020

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