MERIDEAN, DISCOVERY AND PULSAR PACEMAKERS
FDA premarket approval P940031/S019 · decided 1999-06-29
Approval details
- PMA number
- P940031
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MERIDEAN, DISCOVERY AND PULSAR PACEMAKERS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1999-06-07
- Decision date
- 1999-06-29
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for an alternate manufacturing facility located at Guidant Ireland, Cashel Road, Clonmel Tipperary, Ireland and an alternate sterilization sited located at Isotron Ireland Ltd., Sragh Industrial Estate, Tullamore, Co. Offaly, Ireland.
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