PMA P880086S344
- Device
- P880086 Endurity PM1162, PM2162; Endurity Core PM1140, PM2140; AV Plus Dx Lead 1368; Verity ADx XL 5357M/S, 5356, 5256,
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S344
- Product code
- DXY
- Decision date
- 2025-06-18
- Classification
- Cardiovascular
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- changing the bioburden action level/action limit requirements
Current openFDA PMA Record#
- Device
- P880086 Endurity PM1162, PM2162; Endurity Core PM1140, PM2140; AV Plus Dx Lead 1368; Verity ADx XL 5357M/S, 5356, 5256,
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S344
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2025-06-18
- Decision code
- OK30
- Date received
- 2025-05-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changing the bioburden action level/action limit requirements