LATITUDE COMMUNICATOR
FDA premarket approval P910077/S132 · decided 2013-03-13
Approval details
- PMA number
- P910077
- Supplement
- S132
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LATITUDE COMMUNICATOR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2013-02-12
- Decision date
- 2013-03-13
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- MECHANICAL MODIFICATION TO FLEXIBLE PRINTED CIRCUITS AND MODIFICATIONS TO THE SOLDERING PROCESS PARAMETERS FOR THOSE CIRCUITS.
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