PMA P010015S025
- Device
- INSYNC/INSYNC III CRT-IPGS
- Applicant
- Medtronic, Inc.
- PMA number
- P010015
- Supplement
- S025
- Product code
- LWP
- Decision date
- 2006-11-15
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- REDUCTION IN THE NUMBER OF SEAMWELD PENETRATION MONITORING SAMPLES AND A MINOR MODIFICATION IN PROCESSING OF SEAMWELD DATA.
Current openFDA PMA Record#
- Device
- INSYNC/INSYNC III CRT-IPGS
- Applicant
- Medtronic, Inc.
- PMA number
- P010015
- Supplement
- S025
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2006-11-15
- Decision code
- OK30
- Date received
- 2006-10-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REDUCTION IN THE NUMBER OF SEAMWELD PENETRATION MONITORING SAMPLES AND A MINOR MODIFICATION IN PROCESSING OF SEAMWELD DATA.