ST JUDE MEDICAL TENDRIL ST MODEL 1888 LEAD
FDA premarket approval P960013/S045 · decided 2009-04-16
Approval details
- PMA number
- P960013
- Supplement
- S045
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ST JUDE MEDICAL TENDRIL ST MODEL 1888 LEAD
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2009-03-19
- Decision date
- 2009-04-16
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR MINOR LABELING CHANGES THAT ENHANCE INSTRUCTIONS FOR SAFE DEVICE USE IN THE TENDRIL ST MODEL 1888 USER¿S MANUAL.
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