- Device
- ADDVENT/AFFINITY/IDENTITY/VERITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT/TRILOGY/SYNCHRONY/PARAGON/PHOENIX PACEMAKERS/CRT-PS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S184
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2010-01-22
- Decision code
- OK30
- Date received
- 2009-12-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE PROCESS WATER SYSTEM MONITORING FREQUENCY AND LOCATIONS AT ARECIBO, PUERTO RICO MANUFACTURING FACILITY.