PMA P010012S335
- Device
- INCEPTA,ENERGEN,PUNCTUA CRTS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S335
- Product code
- LWP
- Decision date
- 2013-07-30
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- CHANGE TO THE VACUUM BAKE DURATION AND NUMBER OF OPTIONAL RE-BAKES FOR AN ELECTRICAL COMPONENT IN THE PULSE GENERATORS FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- INCEPTA,ENERGEN,PUNCTUA CRTS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S335
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2013-07-30
- Decision code
- OK30
- Date received
- 2013-07-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE VACUUM BAKE DURATION AND NUMBER OF OPTIONAL RE-BAKES FOR AN ELECTRICAL COMPONENT IN THE PULSE GENERATORS FOR THE DEVICES.