DISCOVERY & MERIDIAN DEVICE
FDA premarket approval P940031/S034 · decided 2005-04-08
Approval details
- PMA number
- P940031
- Supplement
- S034
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DISCOVERY & MERIDIAN DEVICE
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2005-03-18
- Decision date
- 2005-04-08
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE USE OF A LUBRICANT, MED-420 ON SEAL PLUGS OF THE HEART FAILURE, TACHY AND BRADY DEVICES.
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