PMA P010012S214
- Device
- COGNIS FAMILY
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S214
- Product code
- LWP
- Decision date
- 2009-06-26
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- CHANGES TO: 1) MOVE THE FABRICATION OF THE L-TAB FROM AN OUTSIDE VENDOR TO IN-HOUSE; 2) ETCH THE TAB INSTEAD OF STAMPING IT; 3) ADD AN ALUMINUM SHEET METAL CONTRACTOR; AND 4) REVISE TWO DIMENSIONS OF THE TAB.
Current openFDA PMA Record#
- Device
- COGNIS FAMILY
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S214
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2009-06-26
- Decision code
- OK30
- Date received
- 2009-05-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO: 1) MOVE THE FABRICATION OF THE L-TAB FROM AN OUTSIDE VENDOR TO IN-HOUSE; 2) ETCH THE TAB INSTEAD OF STAMPING IT; 3) ADD AN ALUMINUM SHEET METAL CONTRACTOR; AND 4) REVISE TWO DIMENSIONS OF THE TAB.