PMA P960013S035

Device: TENDRIL, TENDRIL ST, AND OPTISENSE LEADS
Applicant: ABBOTT MEDICAL
PMA number: P960013
Supplement: S035
Product code: NVZ
Decision date: 2008-05-16
Generic name: Pulse generator, permanent, implantable
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERI-TECH, INC., SALINAS, PUERTO RICO FOR ETHYLENE OXIDE STERILIZATION OF THE PACEMAKERS, ICDS AND LEADS.

Current openFDA PMA Record#

Device: TENDRIL, TENDRIL ST, AND OPTISENSE LEADS
Applicant: ABBOTT MEDICAL
PMA number: P960013
Supplement: S035
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2008-05-16
Decision code: APPR
Date received: 2007-10-19
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERI-TECH, INC., SALINAS, PUERTO RICO FOR ETHYLENE OXIDE STERILIZATION OF THE PACEMAKERS, ICDS AND LEADS.