SOFTWARE APPLICATION MODEL 2890 VERSION 4.10
FDA premarket approval P940031/S028 · decided 2003-10-31
Approval details
- PMA number
- P940031
- Supplement
- S028
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SOFTWARE APPLICATION MODEL 2890 VERSION 4.10
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2003-09-08
- Decision date
- 2003-10-31
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE SOFTWARE APPLICATIONS FOR THE PULSAR, PULSAR MAX, DISCOVERY, MERIDIAN, CONTAK TR, PULSAR MAX II, AND DISCOVERY II PACEMAKER SYSTEMS.
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