PMA P830060S055
- Device
- LEAD ADAPTERS MODEL 6833, 6836, 6931
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S055
- Product code
- LWS
- Decision date
- 2004-07-06
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- CHANGE IN THE SUPPLIER FOR THE MOLD RELEASE, A CHANGE IN THE TYPE OF LUBRICANT, AND A CHANGE IN THE PROCESS OF APPLYING THE LUBRICANT.
Current openFDA PMA Record#
- Device
- LEAD ADAPTERS MODEL 6833, 6836, 6931
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S055
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2004-07-06
- Decision code
- OK30
- Date received
- 2004-06-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE SUPPLIER FOR THE MOLD RELEASE, A CHANGE IN THE TYPE OF LUBRICANT, AND A CHANGE IN THE PROCESS OF APPLYING THE LUBRICANT.