PMA P990001S092

Device: VITATRON DA+C & VITATRON DA+T SERIES IPGS
Applicant: Medtronic, Inc.
PMA number: P990001
Supplement: S092
Product code: NVZ
Decision date: 2011-08-04
Generic name: Pulse generator, permanent, implantable
Approval order statement: MANUFACTURING PROCESS CHANGE FOR THE DETERMINATION OF WORST CASE DEVICE REPRESENTATIVE FOR ETHYLENE OXIDE (EO) RESIDUAL TESTING FOR ETHYLENE OXIDE STERILIZATION.

Current openFDA PMA Record

Device: VITATRON DA+C & VITATRON DA+T SERIES IPGS
Applicant: Medtronic, Inc.
PMA number: P990001
Supplement: S092
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2011-08-04
Decision code: OK30
Date received: 2011-07-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: MANUFACTURING PROCESS CHANGE FOR THE DETERMINATION OF WORST CASE DEVICE REPRESENTATIVE FOR ETHYLENE OXIDE (EO) RESIDUAL TESTING FOR ETHYLENE OXIDE STERILIZATION.