PMA P970013S098
- Device
- Microny II SR+
- Applicant
- ABBOTT MEDICAL
- PMA number
- P970013
- Supplement
- S098
- Product code
- LWO
- Decision date
- 2025-05-22
- Classification
- Cardiovascular
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Approval order statement
- an alternate and additional supplier for the sterile barrier Tyvek lids used in Cardiac Rhythm Management (CRM) devices
Current openFDA PMA Record#
- Device
- Microny II SR+
- Applicant
- ABBOTT MEDICAL
- PMA number
- P970013
- Supplement
- S098
- Product code
- LWO
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Decision date
- 2025-05-22
- Decision code
- OK30
- Date received
- 2025-04-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternate and additional supplier for the sterile barrier Tyvek lids used in Cardiac Rhythm Management (CRM) devices