PMA P010012S079
- Device
- RENEWAL 3 RF CRT-D, MODELS H210, H215, H217 AND H219
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S079
- Product code
- LWP
- Decision date
- 2005-11-23
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- CHANGE FOR THE REMOVAL OF ZOOM E3 TEST FROM THE BUILD PROCESS.
Current openFDA PMA Record#
- Device
- RENEWAL 3 RF CRT-D, MODELS H210, H215, H217 AND H219
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S079
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2005-11-23
- Decision code
- OK30
- Date received
- 2005-10-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE FOR THE REMOVAL OF ZOOM E3 TEST FROM THE BUILD PROCESS.