PMA P990001
- Device
- Diva Family(includes Diamond Ii, Ruby Ii, Topaz Ii
- Applicant
- MEDTRONIC Inc.
- PMA number
- P990001
- Supplement
- S122
- Decision date
- 2016-09-06
Current openFDA PMA Record
- Device
- Diva Platform Implantable Pulse Generators; PRO VIT Application Software
- Applicant
- Medtronic, Inc.
- PMA number
- P990001
- Supplement
- S123
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2025-03-20
- Decision code
- APPR
- Date received
- 2025-02-13
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a predetermined change control plan (PCCP) that encompasses the following biocompatibility-related manufacturing changes, provided that they do not impact the properties of the device materials, for the devices under the above PMAs:1. Removal of a processing aid (solvent, lubricant, antifoaming agent, etc.), or cleaning agent2. Removal of a cleaning process3. Change in parameters (temperature, time, sonication, etc.) of a current cleaning process