VENTAK MINI HE AND VENTAK MINI III AICD TM SYSTEMS
FDA premarket approval P910077/S023 · decided 1998-07-31
Approval details
- PMA number
- P910077
- Supplement
- S023
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTAK MINI HE AND VENTAK MINI III AICD TM SYSTEMS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1998-06-24
- Decision date
- 1998-07-31
- Days to decision
- 37 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for an update to the Model 2881 Software Application to inlcude the DELTA/VISTA pacemakers series, resulting in Version 1.3 of the Model 2881 Software Application.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.