DiamondTemp Ablation Catheters

FDA Premarket Approval P200028 S010

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 NumberS010 Date Received02/04/2022 Decision Date03/04/2022 Product Code OAE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-02-04
Decision Date2022-03-04
PMAP200028
SupplementS010
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 NumberS010 Date Received02/04/2022 Decision Date03/04/2022 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  
the Conversion Of ISO Class 8 Cleanroom Space To ISO Class 7 And The Addition Of A Passthrough Window

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.