PMA P910077S128
- Device
- LATITUDE/PROGRAMMER/RECORDER/MONITOR
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S128
- Product code
- LWS
- Decision date
- 2012-11-14
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- MOVING PRODUCTION OF VARIOUS PRINTED CIRCUIT BOARD ASSEMBLIES TO NEW MANUFACTURING LINES AND AN ALTERNATE WATER WASH SYSTEM AT A SUPPLIER LOCATION.
Current openFDA PMA Record#
- Device
- LATITUDE/PROGRAMMER/RECORDER/MONITOR
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S128
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2012-11-14
- Decision code
- OK30
- Date received
- 2012-10-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MOVING PRODUCTION OF VARIOUS PRINTED CIRCUIT BOARD ASSEMBLIES TO NEW MANUFACTURING LINES AND AN ALTERNATE WATER WASH SYSTEM AT A SUPPLIER LOCATION.