ZOOM LATITUDE PROGRAMMING SYSTEM
FDA premarket approval P910077/S057 · decided 2007-03-23
Approval details
- PMA number
- P910077
- Supplement
- S057
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ZOOM LATITUDE PROGRAMMING SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2005-12-15
- Decision date
- 2007-03-23
- Days to decision
- 463 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE DSP SOFTWARE UPGRADE (VERSION 1.19) OF THE MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM.
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