LATITUDE PATIENT MANAGEMENT SYSTEM INDUCTIVE COMMUNICATOR SOFTWARE, VERSION 1.3 (MODEL 6481)
FDA premarket approval P910077/S073 · decided 2007-05-01
Approval details
- PMA number
- P910077
- Supplement
- S073
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LATITUDE PATIENT MANAGEMENT SYSTEM INDUCTIVE COMMUNICATOR SOFTWARE, VERSION 1.3 (MODEL 6481)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2007-02-22
- Decision date
- 2007-05-01
- Days to decision
- 68 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR: 1) A CHANGE TO THE TIME BASE OF THE INDUCTIVE COMMUNICATOR CLOCK AND 2) IMPROVEMENTS TO TELEPHONE DETECTION/DISABLING OF THE CALL-WAITING FEATURE AND IMPROVEMENT OF TELEPHONE DIAL-TONE DETECTION.
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