PMA P970013S074
- Device
- Microny
- Applicant
- ABBOTT MEDICAL
- PMA number
- P970013
- Supplement
- S074
- Product code
- LWO
- Decision date
- 2017-11-08
- Classification
- Pulse-generator, Single Chamber, Sensor Driven, Implantable
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Approval order statement
- Updates to manufacturing operator procedures and operator retraining.
Current openFDA PMA Record#
- Device
- Microny
- Applicant
- ABBOTT MEDICAL
- PMA number
- P970013
- Supplement
- S074
- Product code
- LWO
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Decision date
- 2017-11-08
- Decision code
- OK30
- Date received
- 2017-10-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updates to manufacturing operator procedures and operator retraining.