PMA P970013S077
- Device
- Microny
- Applicant
- ABBOTT MEDICAL
- PMA number
- P970013
- Supplement
- S077
- Product code
- LWO
- Decision date
- 2018-02-22
- Classification
- Pulse-generator, Single Chamber, Sensor Driven, Implantable
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Approval order statement
- Adjust the relative humidity in the device and leads manufacturing and product packaging areas located in the Sylmar, California facility.
Current openFDA PMA Record#
- Device
- Microny
- Applicant
- ABBOTT MEDICAL
- PMA number
- P970013
- Supplement
- S077
- Product code
- LWO
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Decision date
- 2018-02-22
- Decision code
- OK30
- Date received
- 2018-01-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adjust the relative humidity in the device and leads manufacturing and product packaging areas located in the Sylmar, California facility.