AFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILIES OF PACEMAKERS
FDA premarket approval P880086/S146 · decided 2007-05-09
Approval details
- PMA number
- P880086
- Supplement
- S146
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILIES OF PACEMAKERS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2007-04-24
- Decision date
- 2007-05-09
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE ZEPHYR XL SR MODEL 5626 PACEMAKER WHICH UTILIZES THE XL BATTERY MODEL 9438 WHICH IS CURRENTLY APPROVED FOR USE WITH THE MARKETED ZEPHYR XL DR 5826 PACEMAKER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ZEPHYR XL SR MODEL 5626 AND IS INDICATED FOR SINGLE CHAMBER RATE ADAPTIVE PACING.
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