PMA P980035S215
- Device
- ADVISA DR
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S215
- Product code
- NVZ
- Decision date
- 2011-05-05
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- CHANGE TO AN EPOXY DISPENSER PARAMETER, THE IMPLEMENTATION OF A SOFTWARE REVISION FOR A LASER BONDER, AND AN UPDATE TO THE STERILE PACKAGING OPERATION PROCESS.
Current openFDA PMA Record#
- Device
- ADVISA DR
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S215
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2011-05-05
- Decision code
- OK30
- Date received
- 2011-04-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO AN EPOXY DISPENSER PARAMETER, THE IMPLEMENTATION OF A SOFTWARE REVISION FOR A LASER BONDER, AND AN UPDATE TO THE STERILE PACKAGING OPERATION PROCESS.