DISCOVERY/MERIDIAN
FDA premarket approval P940031/S020 · decided 1999-10-22
Approval details
- PMA number
- P940031
- Supplement
- S020
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DISCOVERY/MERIDIAN
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1999-09-30
- Decision date
- 1999-10-22
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for addition of a non-conducting epoxy preform between layers of the "triple stack".
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