ADDVENT MODEL 2060LR PULSE GENERATOR AV PLUS SINGLE PASS LEAD MODEL 1328C
FDA premarket approval P880086/S038 · decided 1999-05-13
Approval details
- PMA number
- P880086
- Supplement
- S038
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ADDVENT MODEL 2060LR PULSE GENERATOR AV PLUS SINGLE PASS LEAD MODEL 1328C
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 1996-08-12
- Decision date
- 1999-05-13
- Days to decision
- 1004 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for the AddVent(R) VDDR Pacing System consisting of Models 2060BL and 2060LR pulse generators and the AV Plus(R) Model 1368 single-pass lead. The indications are specified in Attachment A.
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