Anthem, Allure/RF, Quadra Allure /RF family ofCRT-Ps
FDA premarket approval P030035/S153 · decided 2017-10-20
Approval details
- PMA number
- P030035
- Supplement
- S153
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Anthem, Allure/RF, Quadra Allure /RF family ofCRT-Ps
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-02-01
- Decision date
- 2017-10-20
- Days to decision
- 261 days
- Decision code
- APPR
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for Merlin.net MN5000 v7.5 Software to add support for the Confirm Rx Insertable Cardiac Monitor.
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