PMA P960013S082

Device: TENDRIL SDX, TENDRIL ST, TENDRIL STS, OPTISENSE
Applicant: ABBOTT MEDICAL
PMA number: P960013
Supplement: S082
Product code: NVN
Decision date: 2016-07-19
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Approval order statement: Alternate analytical testing laboratory for the identification testing of dexamethasone sodium phosphate for incoming monolithic controlled release devices.

Current openFDA PMA Record#

Device: TENDRIL SDX, TENDRIL ST, TENDRIL STS, OPTISENSE
Applicant: ABBOTT MEDICAL
PMA number: P960013
Supplement: S082
Product code: NVN
Generic name: Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Decision date: 2016-07-19
Decision code: OK30
Date received: 2016-06-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Alternate analytical testing laboratory for the identification testing of dexamethasone sodium phosphate for incoming monolithic controlled release devices.