DIAMOND AF

FDA Premarket Approval P200028 S014

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

DeviceDIAMOND AF
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
ApplicantMedtronic Inc.8200 Coral Sea Streetmounds View, MN 55112 PMA NumberP200028 Supplement NumberS014 Date Received10/17/2022 Decision Date11/16/2022 Product Code OAE  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
Date Received2022-10-17
Decision Date2022-11-16
PMAP200028
SupplementS014
Product CodeOAE 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination ProductNo
Applicant AddressMedtronic Inc.
8200 Coral Sea Street
mounds View, MN 55112 PMA NumberP200028 Supplement NumberS014 Date Received10/17/2022 Decision Date11/16/2022 Product Code OAE  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement  
approval For Changes To The Protocol Inclusion And Exclusion Criteria

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
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

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