PMA P990001S078

Device: CLARITY/VITATRON DA+C-SERIES/DIAMOND 3/JADE 3/RUBY 3/VITATRON DA+T-SERIES/TOPAZ 3/VITA 2/VITA IPGS
Applicant: Medtronic, Inc.
PMA number: P990001
Supplement: S078
Product code: NVZ
Decision date: 2010-11-23
Generic name: Pulse generator, permanent, implantable
Approval order statement: IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS.

Current openFDA PMA Record

Device: CLARITY/VITATRON DA+C-SERIES/DIAMOND 3/JADE 3/RUBY 3/VITATRON DA+T-SERIES/TOPAZ 3/VITA 2/VITA IPGS
Applicant: Medtronic, Inc.
PMA number: P990001
Supplement: S078
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2010-11-23
Decision code: OK30
Date received: 2010-10-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: IMPLEMENTATION OF AN UPDATED VERSION OF THE STATISTICAL PROCESS CONTROL (SPC) SOFTWARE SYSTEM ACROSS MULTIPLE MANUFACTURING LOCATIONS AND VERTICALLY INTEGRATED SUPPLIERS.