MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM
FDA premarket approval P910077/S046 · decided 2005-02-10
Approval details
- PMA number
- P910077
- Supplement
- S046
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2004-09-01
- Decision date
- 2005-02-10
- Days to decision
- 162 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM. THE MODEL 3120 PRM IS INTENDED TO BE USED AS A COMPLETE SYSTEM TO COMMUNICATE WITH GUIDANT IMPLANTABLE PULSE GENERATORS. THE SOFTWARE IN USE CONTROLS ALL COMMUNICATION FUNCTIONS FOR THE PULSE GENERATOR. FOR DETAILED SOFTWARE APPLICATION INSTRUCTIONS, REFER TO THE SYSTEM GUIDE FOR THE GUIDANT PULSE GENERATOR BEING INTERROGATED.
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