Ellipse hybrid
FDA premarket approval P910023/S420 · decided 2019-10-18
Approval details
- PMA number
- P910023
- Supplement
- S420
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Ellipse hybrid
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2019-09-26
- Decision date
- 2019-10-18
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Alternate supplier for a telemetry coil component used on the Ellipse ICD hybrid.
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