PMA P950024S005
- Device
- CAPSURE EPI 4965/4968
- Applicant
- Medtronic, Inc.
- PMA number
- P950024
- Supplement
- S005
- Product code
- DTB
- Decision date
- 2001-12-11
- Classification
- Permanent Pacemaker Electrode
- Generic name
- permanent pacemaker Electrode
- Approval order statement
- APPROVAL FOR THE ADDITION OF AN ETHYLENE OXIDE GAS CONCENTRATION MONITOR TO A PARAMETRIC RELEASE STERILIZATION PROCESS.
Current openFDA PMA Record#
- Device
- CAPSURE EPI 4965/4968
- Applicant
- Medtronic, Inc.
- PMA number
- P950024
- Supplement
- S005
- Product code
- DTB
- Generic name
- permanent pacemaker Electrode
- Decision date
- 2001-12-11
- Decision code
- APPR
- Date received
- 2001-11-05
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF AN ETHYLENE OXIDE GAS CONCENTRATION MONITOR TO A PARAMETRIC RELEASE STERILIZATION PROCESS.