ZOOM LATITUDE PROGRAMMING SYSTEM
FDA premarket approval P910077/S134 · decided 2013-06-20
Approval details
- PMA number
- P910077
- Supplement
- S134
- 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
- 2013-05-17
- Decision date
- 2013-06-20
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR USE OF AN ALTERNATE ANTENNA (MODEL 3123) WITH THE LATITUDE PROGRAMMER/RECORDER/MONITOR MODEL 3120 AND ASSOCIATED DEVICE LABELING.
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