LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 6482
FDA premarket approval P910077/S062 · decided 2006-06-23
Approval details
- PMA number
- P910077
- Supplement
- S062
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 6482
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2006-05-25
- Decision date
- 2006-06-23
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL TO MODIFY THE INSTRUCTIONS FOR THE LATITUDE CLINICIAN MANUAL.
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