LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE MODELS: 6482 AND 6488
FDA premarket approval P910077/S091 · decided 2008-09-05
Approval details
- PMA number
- P910077
- Supplement
- S091
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE MODELS: 6482 AND 6488
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2008-07-23
- Decision date
- 2008-09-05
- Days to decision
- 44 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR CHANGES TO THE LATITUDE REGULATED APPLICATION SOFTWARE ON LATITUDE SYSTEM SERVER (MODEL 6488, VERSION 5.0).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.