FDA.reportPublic FDA data

PMA P100021S085

Device
Talent Occluder
Applicant
Medtronic Vascular
PMA number
P100021
Supplement
S085
Product code
MIH
Decision date
2020-10-30
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
Changes to the acceptance criteria for the temperature probes during product parameter profile studies conducted during requalification of the sterilization cycle.

Current openFDA PMA Record#

Device
Talent Occluder
Applicant
Medtronic Vascular
PMA number
P100021
Supplement
S085
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2020-10-30
Decision code
OK30
Date received
2020-10-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Changes to the acceptance criteria for the temperature probes during product parameter profile studies conducted during requalification of the sterilization cycle.