DISCOVERY/MERIDIAN PACEMAKER SYSTEMS
FDA premarket approval P940031/S021 · decided 1999-10-20
Approval details
- PMA number
- P940031
- Supplement
- S021
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DISCOVERY/MERIDIAN PACEMAKER SYSTEMS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1999-10-04
- Decision date
- 1999-10-20
- Days to decision
- 16 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for Software Application Model 2890 Revision 3.27 which removes automatic Minute Ventilation (MV) initialization, adds a "pop-up" warning ont he programmer screen prior to manual MV initialization, and corrects several minor anomalies applicable to the entire PDM pacemaker line.
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