PMA P960013S020
- Device
- TENDRIL MODEL 1488T/TC & 1688T/TC LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S020
- Product code
- NVZ
- Decision date
- 2006-06-26
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- CHANGES TO THE INSPECTION PROCESS FOR MEDICAL ADHESIVE ON THE ELECTRODE RING DURING PRODUCTION OF THE LEADS.
Current openFDA PMA Record#
- Device
- TENDRIL MODEL 1488T/TC & 1688T/TC LEADS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S020
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2006-06-26
- Decision code
- OK30
- Date received
- 2006-05-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE INSPECTION PROCESS FOR MEDICAL ADHESIVE ON THE ELECTRODE RING DURING PRODUCTION OF THE LEADS.