PMA P880086S154

Device: PASSIVE FIXATION FAMILY OF LEADS
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S154
Product code: NVZ
Decision date: 2007-10-31
Classification: Pulse Generator, Permanent, Implantable
Generic name: Pulse generator, permanent, implantable
Approval order statement: CHANGE IN THE MANUFACTURING ENVIRONMENT FROM A CLASS 10,000 CLEAN ROOM TO A CLASS 100,000 CLEAN ROOM FOR THE ASSEMBLY OF THE LOW-VOLTAGE AND LEFT VENTRICULAR FAMILIES OF LEADS.

Current openFDA PMA Record#

Device: PASSIVE FIXATION FAMILY OF LEADS
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S154
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2007-10-31
Decision code: OK30
Date received: 2007-09-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE MANUFACTURING ENVIRONMENT FROM A CLASS 10,000 CLEAN ROOM TO A CLASS 100,000 CLEAN ROOM FOR THE ASSEMBLY OF THE LOW-VOLTAGE AND LEFT VENTRICULAR FAMILIES OF LEADS.