VENTRITEX ICD'S USING MODEL 3307, V2.1A PROGRAMMER SOFTWARE
FDA premarket approval P910023/S051 · decided 2001-03-02
Approval details
- PMA number
- P910023
- Supplement
- S051
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTRITEX ICD'S USING MODEL 3307, V2.1A PROGRAMMER SOFTWARE
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2001-02-09
- Decision date
- 2001-03-02
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE PROGRAMMER SOFTWARE MODEL 3307 V2.1.
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