FDA.reportPublic FDA data

PMA P960030S070

Device
Isoflex
Applicant
ABBOTT MEDICAL
PMA number
P960030
Supplement
S070
Product code
NVN
Decision date
2020-10-16
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
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
Isoflex
Applicant
ABBOTT MEDICAL
PMA number
P960030
Supplement
S070
Product code
NVN
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
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.