ST JUDES MEDICAL ICD
FDA premarket approval P910023/S085 · decided 2005-11-28
Approval details
- PMA number
- P910023
- Supplement
- S085
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ST JUDES MEDICAL ICD
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2005-10-11
- Decision date
- 2005-11-28
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE SEPTUM DESIGN OF ALL ST. JUDE MEDICAL ICDS(VR AND DR MODELS.)
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510(k) clearances by this applicant
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