LATITUDE WAVE COMMUNICATOR (MODEL 6498)
FDA premarket approval P910077/S119 · decided 2013-01-28
Approval details
- PMA number
- P910077
- Supplement
- S119
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LATITUDE WAVE COMMUNICATOR (MODEL 6498)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2012-02-09
- Decision date
- 2013-01-28
- Days to decision
- 354 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE LATITUDE WAVE COMMUNICATOR AND SYSTEM SOFTWARE LATITUDE NXT SOFTWARE FOR THE LATITUDE PATIENT MANAGEMENT SYSTEM.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.