3500/3510 PROGRAMMER WITH SOFTWARE MODEL 3303 V1.03
FDA premarket approval P880086/S063 · decided 1999-07-21
Approval details
- PMA number
- P880086
- Supplement
- S063
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 3500/3510 PROGRAMMER WITH SOFTWARE MODEL 3303 V1.03
- Generic name
- Programmer, pacemaker
- Applicant
- ABBOTT MEDICAL
- Date received
- 1999-07-02
- Decision date
- 1999-07-21
- Days to decision
- 19 days
- Decision code
- APPR
- Product code
- KRG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for modifications to the Model 3303 V1.03 programmer software for use with the Models 3500/3510 Programmers.
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