FDA.reportPublic FDA data

PMA P960030S073

Device
IsoFlex
Applicant
ABBOTT MEDICAL
PMA number
P960030
Supplement
S073
Product code
NVN
Decision date
2021-03-18
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement
Implementation of MCRD component manufacturing process improvements and changes associated with the optimized drug release/elution test method for Isoflex leads.

Current openFDA PMA Record#

Device
IsoFlex
Applicant
ABBOTT MEDICAL
PMA number
P960030
Supplement
S073
Product code
NVN
Generic name
Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date
2021-03-18
Decision code
OK30
Date received
2021-02-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of MCRD component manufacturing process improvements and changes associated with the optimized drug release/elution test method for Isoflex leads.