AFFINITY/INTEGRITY/VICTORY/ZEPHR/ACCENT FAMILY OF PACEMAKERS
FDA premarket approval P880086/S249 · decided 2014-12-11
Approval details
- PMA number
- P880086
- Supplement
- S249
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AFFINITY/INTEGRITY/VICTORY/ZEPHR/ACCENT FAMILY OF PACEMAKERS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2014-10-20
- Decision date
- 2014-12-11
- Days to decision
- 52 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR MODEL EX2000 V8.0 SOFTWARE FOR THE MODELS EX1100AND EX1150 MERLIN@HOME TRANSMITTERS USED WITH THE DEVICES.
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