FDA.reportPublic FDA data

PMA P950022S133

Device
Durata and Optisure High Voltage Leads
Applicant
ABBOTT MEDICAL
PMA number
P950022
Supplement
S133
Product code
LWS
Decision date
2020-06-18
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
Inclusion of Abbott SOAL and Abbott RE TEM as alternate test sites; use of a distal subassembly as a surrogate stability test article; and an update to the annual stability protocol.

Current openFDA PMA Record#

Device
Durata and Optisure High Voltage Leads
Applicant
ABBOTT MEDICAL
PMA number
P950022
Supplement
S133
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2020-06-18
Decision code
OK30
Date received
2020-05-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Inclusion of Abbott SOAL and Abbott RE TEM as alternate test sites; use of a distal subassembly as a surrogate stability test article; and an update to the annual stability protocol.