LATITUDE PATIENT MANAGEMENT SYSTEM
FDA premarket approval P910077/S097 · decided 2009-11-25
Approval details
- PMA number
- P910077
- Supplement
- S097
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LATITUDE PATIENT MANAGEMENT SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2009-09-30
- Decision date
- 2009-11-25
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR CHANGES TO THE LATITUDE PATIENT MANAGEMENT SYSTEM G2 RF COMMUNICATOR MODEL 6476 SOFTWARE, VERSION 3.02 AND LATITUDE PATIENT MANAGEMENT SERVER MODEL 6488, VERSION 5.2.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.