PMA P970013
- Device
- Microny family of Pacemakers
- Applicant
- ABBOTT MEDICAL
- PMA number
- P970013
- Supplement
- S091
- Product code
- LWO
- Decision date
- 2026-04-24
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Approval order statement
- the Merlin PCS Programmer Software Model 3330 version 28.8.1
Current openFDA PMA Record#
- Device
- Microny family of Pacemakers
- Applicant
- ABBOTT MEDICAL
- PMA number
- P970013
- Supplement
- S100
- Product code
- LWO
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Decision date
- 2026-04-24
- Decision code
- APPR
- Date received
- 2026-01-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- the Merlin PCS Programmer Software Model 3330 version 28.8.1