DISCOVERY/MERIDIAN/PULSAR PACEMAKERS
FDA premarket approval P940031/S024 · decided 2000-06-20
Approval details
- PMA number
- P940031
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DISCOVERY/MERIDIAN/PULSAR PACEMAKERS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2000-05-09
- Decision date
- 2000-06-20
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL TO MARKET BOTH COATED AND UNCOATED VERSIONS OF THE ABOVE PACEMAKERS.
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