PMA P930039S114
- Device
- CAPSUREFIX LEAD, SUREFIX LEAD
- Applicant
- Medtronic, Inc.
- PMA number
- P930039
- Supplement
- S114
- Product code
- NVY
- Decision date
- 2014-08-14
- Classification
- Permanent Defibrillator Electrodes
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- A MINOR CHANGE TO THE PLASMA TREATMENT PROCESS USED ON SILICONE TUBING.
Current openFDA PMA Record#
- Device
- CAPSUREFIX LEAD, SUREFIX LEAD
- Applicant
- Medtronic, Inc.
- PMA number
- P930039
- Supplement
- S114
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2014-08-14
- Decision code
- OK30
- Date received
- 2014-07-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- A MINOR CHANGE TO THE PLASMA TREATMENT PROCESS USED ON SILICONE TUBING.