PMA P970013S092
- Device
- Microny family of Pacemakers
- Applicant
- ABBOTT MEDICAL
- PMA number
- P970013
- Supplement
- S092
- Product code
- LWO
- Decision date
- 2023-04-14
- Classification
- Cardiovascular
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Approval order statement
- Approval for software changes in the Merlin PCS Model 3330 Software v27.0.1 and Merlint.net MN5000 v8.0.
Current openFDA PMA Record#
- Device
- Microny family of Pacemakers
- Applicant
- ABBOTT MEDICAL
- PMA number
- P970013
- Supplement
- S092
- Product code
- LWO
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Decision date
- 2023-04-14
- Decision code
- APPR
- Date received
- 2023-02-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software changes in the Merlin PCS Model 3330 Software v27.0.1 and Merlint.net MN5000 v8.0.