FDA.reportPublic FDA data

PMA P950022S135

Device
Durata, Optisure
Applicant
ABBOTT MEDICAL
PMA number
P950022
Supplement
S135
Product code
LWS
Decision date
2020-10-16
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
Approval for the use of an optimized method for the calculation of the amount of DSP content identified on product labels for CRT and passive fixation cardiac lead.

Current openFDA PMA Record#

Device
Durata, Optisure
Applicant
ABBOTT MEDICAL
PMA number
P950022
Supplement
S135
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2020-10-16
Decision code
APPR
Date received
2020-08-11
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for the use of an optimized method for the calculation of the amount of DSP content identified on product labels for CRT and passive fixation cardiac lead.