MODEL 3120 ZOOM LATITUDE PROGRAMMER
FDA premarket approval P910077/S104 · decided 2010-05-19
Approval details
- PMA number
- P910077
- Supplement
- S104
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 3120 ZOOM LATITUDE PROGRAMMER
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2010-03-24
- Decision date
- 2010-05-19
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR A MINOR DESIGN CHANGE TO THE MODEL 3120 ZOOM LATITUDE PROGRAMMER AND AN ALTERNATE SUPPLIER FOR THE HARD DRIVE COMPONENT IN THE PROGRAMMER.
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