PMA P960013S133

Device: UltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999, Isoflex Low Voltage 1944/1948, Ten
Applicant: ABBOTT MEDICAL
PMA number: P960013
Supplement: S133
Product code: NVN
Decision date: 2026-06-11
Classification: Cardiovascular
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement: approval for a predetermined change control plan (PCCP) that encompasses a the installation and validation of a semi-automated device packaging line and a cleanroom expansion of current ISO 7 cleanrooms into recently converted ISO 7 cleanrooms at Abbott’s bradycardia lead manufacturing site. The supplement also requested approval for conversion of some ISO 8 cleanrooms into ISO 7 cleanrooms, which will subsequently be expanded as part of the PCCP.

Current openFDA PMA Record#

Device: UltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999, Isoflex Low Voltage 1944/1948, Ten
Applicant: ABBOTT MEDICAL
PMA number: P960013
Supplement: S133
Product code: NVN
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date: 2026-06-11
Decision code: APPR
Date received: 2026-05-06
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a predetermined change control plan (PCCP) that encompasses a the installation and validation of a semi-automated device packaging line and a cleanroom expansion of current ISO 7 cleanrooms into recently converted ISO 7 cleanrooms at Abbott’s bradycardia lead manufacturing site. The supplement also requested approval for conversion of some ISO 8 cleanrooms into ISO 7 cleanrooms, which will subsequently be expanded as part of the PCCP.