PMA P880086S343
- Device
- Zephyr XL DR, Zephyr DR, Zephyr SR, Zephyr XL SR, Verity ADX XL VDR
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S343
- Product code
- DXY
- Decision date
- 2025-05-22
- Classification
- Cardiovascular
- Generic name
- implantable pacemaker Pulse-generator
- 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
- Zephyr XL DR, Zephyr DR, Zephyr SR, Zephyr XL SR, Verity ADX XL VDR
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S343
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- 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