FDA.reportPublic FDA data

PMA P130026S073

Device
TactiSys Quartz Equipment
Applicant
St Jude Medical
PMA number
P130026
Supplement
S073
Product code
OAE
Decision date
2021-05-21
Generic name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement
Software changes to the non-product test systems including an update to the operating systems and the introduction of digitally validated records and signatures.

Current openFDA PMA Record#

Device
TactiSys Quartz Equipment
Applicant
St Jude Medical
PMA number
P130026
Supplement
S073
Product code
OAE
Generic name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision date
2021-05-21
Decision code
OK30
Date received
2021-05-05
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Software changes to the non-product test systems including an update to the operating systems and the introduction of digitally validated records and signatures.