PMA P980035S641

Device: MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S641
Product code: NVZ
Decision date: 2020-09-25
Generic name: Pulse generator, permanent, implantable
Approval order statement: Implementation of modifications to the medical adhesive process for selected pulse generators as part of the backfill hole weld rework process.

Current openFDA PMA Record#

Device: MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S641
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2020-09-25
Decision code: OK30
Date received: 2020-09-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of modifications to the medical adhesive process for selected pulse generators as part of the backfill hole weld rework process.