ICD FAMILY OF DEVICES & FORTIFY FAMILY OF DEVICES
FDA premarket approval P910023/S295 · decided 2012-08-09
Approval details
- PMA number
- P910023
- Supplement
- S295
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ICD FAMILY OF DEVICES & FORTIFY FAMILY OF DEVICES
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2012-05-25
- Decision date
- 2012-08-09
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL OF MODEL MN5000 VERSION 6.1 SOFTWARE TO BE USED WITH THE MERLIN.NET SYSTEN AND FOR THE MODEL EX2000 VERSION 6.1 SOFTWARE TO BE USED ON MERLIN AT HOME DEVICES.
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