PMA P010012S077
- Device
- CONTAK RENEWAL 3
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S077
- Product code
- LWP
- Decision date
- 2005-12-21
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR THE ADDITION OF INSPECTION TESTS, MATERIALS, ALTERNATE SUPPLIERS AND MANUFACTURING INSTRUCTIONS.
Current openFDA PMA Record#
- Device
- CONTAK RENEWAL 3
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S077
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2005-12-21
- Decision code
- APPR
- Date received
- 2005-10-03
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF INSPECTION TESTS, MATERIALS, ALTERNATE SUPPLIERS AND MANUFACTURING INSTRUCTIONS.