LATITUDE INDUCTIVE PATIENT MANAGEMENT COMMUNICATOR
FDA premarket approval P910077/S080 · decided 2007-11-14
Approval details
- PMA number
- P910077
- Supplement
- S080
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LATITUDE INDUCTIVE PATIENT MANAGEMENT COMMUNICATOR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2007-10-11
- Decision date
- 2007-11-14
- Days to decision
- 34 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- REPLACEMENT OF THE DEPANELIZATION EQUIPMENT AND ENHANCEMENT OF A VISUAL INSPECTION FOR THE DAUGHTER BOARD OF THE DEVICE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.