DISCOVERY & MERIDIAN PULSE GENERATORS
FDA premarket approval P940031/S018 · decided 1999-05-06
Approval details
- PMA number
- P940031
- Supplement
- S018
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DISCOVERY & MERIDIAN PULSE GENERATORS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1999-03-03
- Decision date
- 1999-05-06
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the introduction of an alternative lid for the accelerometer (to metal from ceramic) and the use of a silver thermoplastic to bond the accelerometer to the hybrid instead of epoxy.
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