PMA P010012S253
- Device
- EASYTRAK
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S253
- Product code
- LWP
- Decision date
- 2010-09-22
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- CHANGE TO THE SHELF-LIFE EXPIRATION OF POLYURETHANE TUBING FROM 36 MONTHS TO ¿INDEFINITE¿.
Current openFDA PMA Record#
- Device
- EASYTRAK
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S253
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2010-09-22
- Decision code
- OK30
- Date received
- 2010-08-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE SHELF-LIFE EXPIRATION OF POLYURETHANE TUBING FROM 36 MONTHS TO ¿INDEFINITE¿.