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PMA P960030S069

Device
Isoflex
Applicant
ABBOTT MEDICAL
PMA number
P960030
Supplement
S069
Product code
NVN
Decision date
2020-06-18
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
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
Isoflex
Applicant
ABBOTT MEDICAL
PMA number
P960030
Supplement
S069
Product code
NVN
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
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.