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.
Approval for changes to the visual inspection methodology and acceptance criteria for a laser welding process
|Device||DiamondTemp Ablation Catheters|
|Generic Name||Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation|
|Supplement Type||30-day Notice|
|Supplement Reason||Process Change - Manufacturer/sterilizer/packager/supplier|
|Applicant Address||Medtronic Inc. 8200 Coral Sea Street mounds View, MN 55112|
|Supplement Number||Date||Supplement Type|