TENDRIL 1688T/TC LEADS
FDA premarket approval P960013/S024 · decided 2006-12-11
Approval details
- PMA number
- P960013
- Supplement
- S024
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TENDRIL 1688T/TC LEADS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2006-11-21
- Decision date
- 2006-12-11
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- REVISION TO THE WELD PROCESS OF THE INNER COIL TO THE SHAFT COUPLING/SPRING ASSEMBLY.
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