MEDTRONIC SIGMA SERIES PULSE GENERATORS AND MODEL 9963/A SOFTWARE
FDA premarket approval P980035/S002 · decided 1999-08-09
Approval details
- PMA number
- P980035
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC SIGMA SERIES PULSE GENERATORS AND MODEL 9963/A SOFTWARE
- Applicant
- Medtronic, Inc.
- Date received
- 1999-03-10
- Decision date
- 1999-08-09
- Days to decision
- 152 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Sigma family of pulse generators & software. The DR & SR series are indicated for rate adaptive pacing in pts who may benefit fr increased pacing rates concurrent w/increases in activity. The DR & D Series, SR & S Series, & VVI series are indicated for accepted pt conditions warranting chronic cardiac pacing which include:Symptomatic paroxysmal or permanent second- or third-degree AV block; Symptomatic bilateral bundle branch block; Symptomatic paroxysmal or transient sinus node dysfunctions w/o
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