PROGRAMMER SOFTWARE APPLICATION MODEL 2812 VERSION 1.3
FDA premarket approval P960040/S049 · decided 2005-02-18
Approval details
- PMA number
- P960040
- Supplement
- S049
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROGRAMMER SOFTWARE APPLICATION MODEL 2812 VERSION 1.3
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2004-11-26
- Decision date
- 2005-02-18
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE APPLICATION SOFTWARE MODEL 2812 VERSION 1.3.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.