ADDVENT/AV PLUS DX
FDA premarket approval P880086/S064 · decided 1999-07-23
Approval details
- PMA number
- P880086
- Supplement
- S064
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ADDVENT/AV PLUS DX
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 1999-07-01
- Decision date
- 1999-07-23
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for an extension of the approved shelf life for the device including pulse generator Models 2060BL and 2060LR (12 to 18 months), and the Model 1368 Single Pass Lead (12 to 24 months).
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