PMA P940008S028
- Device
- LEAD TERMINAL CAP
- Applicant
- Boston Scientific
- PMA number
- P940008
- Supplement
- S028
- Product code
- LWS
- Decision date
- 2011-12-23
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- ADDITION OF AN ALTERNATE SECOND SOURCE SUPPLIER FOR ACCESSORIES TO IMPLANTABLE LEADS.
Current openFDA PMA Record
- Device
- LEAD TERMINAL CAP
- Applicant
- Boston Scientific
- PMA number
- P940008
- Supplement
- S028
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2011-12-23
- Decision code
- OK30
- Date received
- 2011-11-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN ALTERNATE SECOND SOURCE SUPPLIER FOR ACCESSORIES TO IMPLANTABLE LEADS.