LATITUDE* PATIENT MANAGEMENT SYSTEM MODELS 6481 AND 6482
FDA premarket approval P910077/S072 · decided 2007-03-09
Approval details
- PMA number
- P910077
- Supplement
- S072
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LATITUDE* PATIENT MANAGEMENT SYSTEM MODELS 6481 AND 6482
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2007-02-08
- Decision date
- 2007-03-09
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR LABELING CHANGES TO THE LATITUDE* PATIENT MANAGEMENT SYSTEM MODELS 6481 AND 6482 WHICH IS USED WITH THE PRIZM, VITALITY, CONTAK AND RENEWAL FAMILIES OF DEVICES. SPECIFICALLY, THE LABELING CHANGES INCLUDE THE INTRODUCTION OF ERRATA SHEETS TO ADDRESS THE FOLLOWING ISSUES: 1) YELLOW ALERT NOTIFICATION; 2) HEART RATE DISPLAY; AND 3) WEIGHT ALERT.
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