PMA P010012S022
- Device
- EASYTRAK IS-1 LEAD, MODELS 4535, 4536, 4537, 4538; EASYTRAK 1 LEAD MODELS 4510, 4511, 4512, 4513
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S022
- Product code
- NIK
- Decision date
- 2004-02-12
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- APPROVAL TO MODIFY LEAD MANUALS.
Current openFDA PMA Record#
- Device
- EASYTRAK IS-1 LEAD, MODELS 4535, 4536, 4537, 4538; EASYTRAK 1 LEAD MODELS 4510, 4511, 4512, 4513
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S022
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2004-02-12
- Decision code
- APPR
- Date received
- 2004-01-16
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO MODIFY LEAD MANUALS.