PMA P910077S112
- Device
- LATITUDE COMMUNICATORS
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S112
- Product code
- LWS
- Decision date
- 2011-04-29
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- REWORK OF PRINTED CIRCUIT ASSEMBLIES (PCAS) USED IN THE MANUFACTURE OF THE LATITUDE¿ COMMUNICATOR.
Current openFDA PMA Record#
- Device
- LATITUDE COMMUNICATORS
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S112
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2011-04-29
- Decision code
- OK30
- Date received
- 2011-03-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REWORK OF PRINTED CIRCUIT ASSEMBLIES (PCAS) USED IN THE MANUFACTURE OF THE LATITUDE¿ COMMUNICATOR.