PMA P010012S342
- Device
- COGNIS,ENERGEN,INCEPTA,PUNCTUA CRT-DS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S342
- Product code
- LWP
- Decision date
- 2013-11-26
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- ADD INSTRUCTIONS FOR CLEANING THE SEAL PLUG BOND AREA OF THE POLYURETHANEHEADERS OF THE ABOVE REFERENCED DEVICES TO THE APPROPRIATE WORK INSTRUCTIONS.
Current openFDA PMA Record#
- Device
- COGNIS,ENERGEN,INCEPTA,PUNCTUA CRT-DS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S342
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2013-11-26
- Decision code
- OK30
- Date received
- 2013-10-29
- Supplement type
- 30-Day Notice
- Approval order statement
- ADD INSTRUCTIONS FOR CLEANING THE SEAL PLUG BOND AREA OF THE POLYURETHANEHEADERS OF THE ABOVE REFERENCED DEVICES TO THE APPROPRIATE WORK INSTRUCTIONS.