FDA.reportPublic FDA data

PMA P100040S053

Device
Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Thoracic Stent Graft (FreeFlo Tapers Line Extens
Applicant
Medtronic Vascular
PMA number
P100040
Supplement
S053
Product code
MIH
Decision date
2022-11-01
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
Automation of a verification step undertaken by Sterile Release Personnel (SRP) for Limulus amebocyte lysate (LAL) Bacterial Endotoxin Testing (BET) prior to final release of product.

Current openFDA PMA Record#

Device
Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Thoracic Stent Graft (FreeFlo Tapers Line Extens
Applicant
Medtronic Vascular
PMA number
P100040
Supplement
S053
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2022-11-01
Decision code
OK30
Date received
2022-10-31
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Automation of a verification step undertaken by Sterile Release Personnel (SRP) for Limulus amebocyte lysate (LAL) Bacterial Endotoxin Testing (BET) prior to final release of product.