PMA P820076S025
- Device
- ICS 3000 IMPLANT MODULE AUTOMATED TEST
- Applicant
- Biotronik, Inc.
- PMA number
- P820076
- Supplement
- S025
- Product code
- LWP
- Decision date
- 2012-02-24
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR ADDITION OF AN AUTOMATED PRODUCTION TEST PROCESS.
Current openFDA PMA Record#
- Device
- ICS 3000 IMPLANT MODULE AUTOMATED TEST
- Applicant
- Biotronik, Inc.
- PMA number
- P820076
- Supplement
- S025
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2012-02-24
- Decision code
- APPR
- Date received
- 2011-06-16
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR ADDITION OF AN AUTOMATED PRODUCTION TEST PROCESS.