LOCATOR STEERABLE STYLET MODEL 4036
FDA premarket approval P960013/S002 · decided 1998-06-15
Approval details
- PMA number
- P960013
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LOCATOR STEERABLE STYLET MODEL 4036
- Generic name
- permanent pacemaker Electrode
- Applicant
- ABBOTT MEDICAL
- Date received
- 1997-12-12
- Decision date
- 1998-06-15
- Days to decision
- 185 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
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