POLARITY PULSE GENERATOR MODELS 209K AND 2091M/S
FDA premarket approval P880086/S047 · decided 1999-09-13
Approval details
- PMA number
- P880086
- Supplement
- S047
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- POLARITY PULSE GENERATOR MODELS 209K AND 2091M/S
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 1998-06-12
- Decision date
- 1999-09-13
- Days to decision
- 458 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for the Polarity Pulse Generator Models 2091K and 2091M/S.
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