TENDRIL MODEL 1488T/TC AND 1688T/TC LEADS
FDA premarket approval P960013/S016 · decided 2006-03-02
Approval details
- PMA number
- P960013
- Supplement
- S016
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TENDRIL MODEL 1488T/TC AND 1688T/TC LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- ABBOTT MEDICAL
- Date received
- 2006-02-06
- Decision date
- 2006-03-02
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- ADDITION OF AN INSPECTION FOR MEDICAL ADHESIVE ON THE HELIX DURING PRODUCTION.
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