PMA P010012S365
- Device
- ACUITY SPIRAL, EASYTRAK 2 LV-1, EASYTRAK 2 IS-1, EASYTRAK 3 LV-1, EASYTRAK 3 IS-1
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S365
- Product code
- LWP
- Decision date
- 2014-08-15
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- REMOVAL OF THE 36-MONTH SHELF LIFE FOR POLYURETHANE TUBING.
Current openFDA PMA Record#
- Device
- ACUITY SPIRAL, EASYTRAK 2 LV-1, EASYTRAK 2 IS-1, EASYTRAK 3 LV-1, EASYTRAK 3 IS-1
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S365
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2014-08-15
- Decision code
- OK30
- Date received
- 2014-07-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REMOVAL OF THE 36-MONTH SHELF LIFE FOR POLYURETHANE TUBING.