PMA P970013S073
- Device
- Microny 2525T
- Applicant
- ABBOTT MEDICAL
- PMA number
- P970013
- Supplement
- S073
- Product code
- LWO
- Decision date
- 2017-10-16
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Approval order statement
- Automation of the tray packaging inspection process to ensure the required components are in the tray.
Current openFDA PMA Record#
- Device
- Microny 2525T
- Applicant
- ABBOTT MEDICAL
- PMA number
- P970013
- Supplement
- S073
- Product code
- LWO
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Decision date
- 2017-10-16
- Decision code
- OK30
- Date received
- 2017-09-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Automation of the tray packaging inspection process to ensure the required components are in the tray.