PMA P910077S118
- Device
- ENDOTAK SQ ARRAY XP SUBCUTANEOUS LEAD
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S118
- Product code
- LWS
- Decision date
- 2012-02-29
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- CHANGE TO THE BACTERIAL ENDOTOXIN SAMPLING PLAN.
Current openFDA PMA Record#
- Device
- ENDOTAK SQ ARRAY XP SUBCUTANEOUS LEAD
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S118
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2012-02-29
- Decision code
- OK30
- Date received
- 2012-01-24
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE TO THE BACTERIAL ENDOTOXIN SAMPLING PLAN.