PMA P970013S085
- Device
- Microny family of Pacemakers
- Applicant
- ABBOTT MEDICAL
- Product code
- LWO
- Decision date
- 2021-09-15
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Approval order statement
- Approval for the Merlin 2 PCS Programmer Model MER3700 with Model MER3400 Software.
Current openFDA PMA Record#
- Device
- Microny family of Pacemakers
- Applicant
- ABBOTT MEDICAL
- PMA number
- P970013
- Supplement
- S085
- Product code
- LWO
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Decision date
- 2021-09-15
- Decision code
- APPR
- Date received
- 2021-01-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Merlin 2 PCS Programmer Model MER3700 with Model MER3400 Software.