DiamondTemp Ablation System

FDA Premarket Approval P200028 S007

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

Changes in the bioburden sampling plan and an expansion in the number of sterilization chambers and pallets

DeviceDiamondTemp Ablation System
Generic NameCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
ApplicantMedtronic Inc.
Date Received2021-09-27
Decision Date2021-10-27
PMAP200028
SupplementS007
Product CodeOAE 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Medtronic Inc. 8200 Coral Sea Street mounds View, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P200028Original Filing
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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