MODEL 3120 ZOOM LATITUDE PROGRAMMER/ RECORDER/MONITOR, MODEL 3122 ANTENNA ACCESSORY, AND CONSULT PROGRAMMER SOFTWARE...
FDA premarket approval P910077/S050 · decided 2005-08-15
Approval details
- PMA number
- P910077
- Supplement
- S050
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 3120 ZOOM LATITUDE PROGRAMMER/ RECORDER/MONITOR, MODEL 3122 ANTENNA ACCESSORY, AND CONSULT PROGRAMMER SOFTWARE...
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2005-03-04
- Decision date
- 2005-08-15
- Days to decision
- 164 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE ADDITION OF A SECOND INTERNAL ANTENNA TO THE MODEL 3120 ZOOM LATITUDE PROGRAMMER/RECORDER/MONITOR, A LABELING UPDATE FOR THE MODEL 3122 ANTENNA ACCESSORY, CONSULT PROGRAMMER SOFTWARE APPLICATION MODEL 2845 VERSION 4.12, AND MINOR MANUFACTURING PROCESS CHANGES.
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