PMA P970013S070
- Device
- Microny SR+ Regency SC+
- Applicant
- ABBOTT MEDICAL
- PMA number
- P970013
- Supplement
- S070
- Product code
- LWO
- Decision date
- 2017-10-20
- Classification
- Pulse-generator, Single Chamber, Sensor Driven, Implantable
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Approval order statement
- Approval for the Merlin Patient Care System (PCS) Model 3330 version 23.0.1 Software for the Merlin PCS Model 3650 Programmer.
Current openFDA PMA Record#
- Device
- Microny SR+ Regency SC+
- Applicant
- ABBOTT MEDICAL
- PMA number
- P970013
- Supplement
- S070
- Product code
- LWO
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Decision date
- 2017-10-20
- Decision code
- APPR
- Date received
- 2017-02-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Merlin Patient Care System (PCS) Model 3330 version 23.0.1 Software for the Merlin PCS Model 3650 Programmer.