ADDVENT/AFFINITY/IDENTITY/VERITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT/TRILOGY/SYNCHRONY/PARAGON/PHOENIX PACEMAKERS/CRT-PS
FDA premarket approval P880086/S184 · decided 2010-01-22
Approval details
- PMA number
- P880086
- Supplement
- S184
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADDVENT/AFFINITY/IDENTITY/VERITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT/TRILOGY/SYNCHRONY/PARAGON/PHOENIX PACEMAKERS/CRT-PS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2009-12-24
- Decision date
- 2010-01-22
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- CHANGE IN THE PROCESS WATER SYSTEM MONITORING FREQUENCY AND LOCATIONS AT ARECIBO, PUERTO RICO MANUFACTURING FACILITY.
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