VICTORY PULSE GENERATOR MODELS: XL DR 5816, DR 5810 AND SR 5610
FDA premarket approval P880086/S108 · decided 2005-12-07
Approval details
- PMA number
- P880086
- Supplement
- S108
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VICTORY PULSE GENERATOR MODELS: XL DR 5816, DR 5810 AND SR 5610
- Generic name
- Programmer, pacemaker
- Applicant
- ABBOTT MEDICAL
- Date received
- 2005-08-30
- Decision date
- 2005-12-07
- Days to decision
- 99 days
- Decision code
- APPR
- Product code
- KRG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE VICTORY PULSE GENERATOR MODELS XL DR 5816, DR 5810 AND SR 5610.
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